(TIỂU LUẬN) TOPIC CRONOBACTER INFECTIONS LINKED TO POWDERED INFANT FORMULA

HO CHI MINH CITY UNIVERSITY OF
TECHNOLOGY AND EDUCATION
FACULTY OF CHEMICAL AND FOOD TECHNOLOGY

SUBJECT: FOOD SAFETY
TOPIC:
CRONOBACTER INFECTIONS
LINKED TO POWDERED INFANT FORMULA
Instructor: Dr. Trương Quang Bình
Group’s Member:
1. Nguyễn Trần Hồng Anh

19116012

2. Trần Tiểu Phụng

19116053

3. Nguyễn Thị Quỳnh Trân

19116013

4. Nguyễn Hoàng Hồng Thắm 19116049
HO CHI MINH CITY, JUNE 2022

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MEMBER’S WORK

Work

Member’s name

Completed or not

Nguyễn Trần Hoàng Anh (Leader)

1; 3.2; 6

Completed

Trần Tiểu Phụng

2.1; 3.1

Completed

Nguyễn Thị Quỳnh Trân

2.2; 4

Completed

Nguyễn Hoàng Hồng Thắm

4;5

Completed

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Table of Contents
1. Introduction ..........................................................................................................1
2. Overview of Powdered infant formula...............................................................2
2.1. Powdered infant formula .............................................................................2
2.2. Processing of powdered infant formula ......................................................3
2.2.1. Preparation of the mix: .........................................................................6
2.2.2. Homogenisation and emulsification: ....................................................8
2.2.3. Heat treatment: ......................................................................................8
2.2.4. Evaporation: ...........................................................................................8
2.2.5. Spray drying: ..........................................................................................9
2.2.6. Packaging:.............................................................................................10
3. Cronobacter illnesses linked powdered infant formula ..................................10
3.1. Cronobacter sakazakii..................................................................................10
3.2. Some reported cases of Cronobacter spp. infections related to powdered
infant formula (PIF) ..........................................................................................16
4. Reasons for the Cronobacter infection in powdered infant formula ............25
5. Recommended solutions ....................................................................................28
5.1. Control in manufacturing environment ...................................................29
5.1.1. Biocides to control Cronobacter ..........................................................29
5.1.2. Essential oils .........................................................................................31
5.1.3. Polyphenols ...........................................................................................32
5.1.4. Prebiotics...............................................................................................33
5.1.5. Risk analysis .........................................................................................33
5.2. Control in the home ....................................................................................37
5.2.1. Reducing the level of contamination through heating reconstituted

PIF prior to use ..............................................................................................37
5.2.2. Minimizing the chance of contamination of reconstituted formula
during preparation.........................................................................................37

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5.2.3. Minimizing the growth of C. sakazakii following reconstitution
prior to consumption .....................................................................................38
5.2.4. Guidelines from Centers for Disease Control and Prevention - U.S.
Department of Health & Human Services...................................................38
6. Conclusion...........................................................................................................42
References ...............................................................................................................45

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1. Introduction
Breastfeeding of young newborns is undeniably preferable to ensure a healthy
child's development. Nevertheless, it is not always feasible to breastfeed. Powdered
infant formula (PIF) is designed to be a supplement to breast milk and can be used
as a substitute if mothers are unable to breastfeed their children[1].
PIF is a low water activity non-sterile product. Therefore, it might contain a
range of bacteria that can grow rapidly following reconstitution[2]. Cronobacter spp.
(formerly Enterobacter sakazakii) is one of the most concerns in powdered infant
formula.

The Cronobacter spp. infections cause neonatal meningitis or necrotizing
enterocolitis and bacteremia, which results in an alarming mortality rate has been
reported [3]. Many cases of Cronobacter spp. infections have been researched that
is linked epidemiologically to powdered infant formula (PIF) [4].
Cronobacter infections are uncommon, but they can be fatal to neonates.
Although the amount of Cronobacter sakazakii has been found only 3 cfu/g in
powdered infant formula [5], time-temperature abuse of prepared formula allows
modest quantities of pollutants to rise, potentially causing illness. Low populations,
on the other hand, have been found to induce sickness even in the absence of abuse
after preparation [6]. According to FAO/WHO in 2008 [7], there were at least 120
reported cases of neonatal and infant Cronobacter spp. infections and 27 fatalities
worldwide. This might be an underestimation due to unreported and misidentified
instances [2] [8].
In particular, most recently, in 2022, there were 4 cases of Cronobacter illness
with 2 deaths believed to be linked to powdered milk. When the source of the
infection was thought to be related to Abbott's powdered infant formula, the incident
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became even more concerning. Furthermore, the FDA's recently disclosed
inspection results document detailing a pattern of deficiencies with food safety
procedures at Abbott's infant formula production plant raises the question of whether
the manufacturing process of this factory causes Cronobacter infections.
Considering the high risk of Cronobacter infections in formula milk as well
as recent infections due to intrinsic contamination or through extrinsic
contamination, our team decided to choose the topic: Cronobacter Infections

Linked to Powdered Infant Formula with the desire to better understand
Cronobacter spp., the causes of infection, and as well as offer recommended
solutions to limit the risk of infection.

2. Overview of Powdered infant formula
2.1. Powdered infant formula [9]
The term "powdered infant formula" refers to a variety of products, including
both breast milk fortifiers and breast milk substitutes. The former are nutritional
supplements added to breast milk, which may not be sufficiently nutritious for the
baby if the baby was born prematurely. In general, the term children less than 1 year in age.

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Figure 1. Similac Infant Formula Powder
This complicates matters because the Salmonella and Cronobacter spp.
microbiological criteria for powdered infant formula are for products with an
intended target age of up to 6 months, after which a more varied diet is introduced
during the "weaning" phase. In some countries, commercially available PIF products
for infants over 6 months are referred to as "follow-up formulas" or "follow-on
formulas" for which the current microbiological criteria for formula= do not apply.
2.2. Processing of powdered infant formula
Dry blending, wet mixing, and a mixture of wet processing and dry blending
are the three types of manufacturing processes used to make powdered infant

formula [10], [11]. The dry blending process begins with the manufacture of
individual ingredients, which are then obtained in powdered form from suppliers,
heat-treated as needed, dried, and then dry-blended. All materials are mixed in a
liquid phase and heat-treated in the wet mixing-spray process. Pasteurization or
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sterilization, for example, is required before they are dry spray. A mixed approach
is sometimes employed, in which some of the ingredients are processed using wet
mixing to generate a foundation powder, and the other ingredients are added using
dry blending [12], [13]. The dry blending technique has the advantage of consuming
less energy and requiring less capital for equipment, construction, and maintenance.
Because there is no water involved in the dry blending process, the risk of microbial
contamination is greatly decreased. However, there are significant drawbacks to
employing the dry blending procedure, such as the microbiological and physical
quality of the finished product being dependent on raw materials, the inability to
integrate oil, and component de-blending during transportation. One of the benefits
of the wet mix technique is that all quality parameters, such as wet mixing,
concentration by evaporation, and spray drying, may be managed more successfully
than with dry mixing. As a result, the microbiological, physical, and chemical
properties of the powder are improved [14]. However, there are certain drawbacks,
such as increased equipment costs, more maintenance, and the presence of both wet
and dry regions in one manufacturing plant.

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Figure 2. Manufacturing process of powdered infant formula by wet mixingspray drying process
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The three key stages of the wet mixing-spray drying process are always the
same: mix preparation, evaporation, and drying.[15]
2.2.1. Preparation of the mix:
The basic components widely used in powdered infant formula are shown in
Table 1. The physical qualities of powdered infant formula wet-mixes are influenced
by the quality and pre-treatment of the ingredients [16]. Fresh skim milk that has
been heat-treated, for example, has been reported to have higher viscosities after
evaporation than fresh skim milk that has not been heat-treated [17].
Table 1. Typical raw material for powdered infant formula [16]

Casein Source

Skim milk powder (SMP), evaporated skim milk, acid
casein, sodium/calcium/potassium caseinate, milk
protein concentrate (MPC*)

Whey Source

Demineralised whey powder (DWP), whey protein
concentrates (WPC*), whey protein isolates (WPI),
hydrolysed whey ingredients

Alternative protein

Soy milk, soy protein isolate, locust bean seed protein,

source

amino acids

Oils

Soy, corn, safflower, sunflower, colza, palm, copra,
structured lipids

Carbohydrates

Lactose, starch, sucrose, corn syrup, corn syrup solids

Major minerals

Calcium carbonate, calcium phosphates, dibasic
magnesium phosphate, potassium citrate, magnesium
chloride
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Minor minerals

Potassium iodide, ferrous sulphate, manganese sulphate,
copper sulphate, zinc sulphate

Vitamins

A, D, E, K, B1, B2, B6, B12, niacin, folic acid,
pantothenic acid, biotine, choline, inositol

Functional

Soy lecithin, mono- and diglycerides

ingredients

Before mixing, these items must be prepared and hydrated. Powder hydration
is usually divided into multiple stages, including wetting, sinking, dispersion, and
dissolution [18]. To minimize hydration time, high shear devices can be utilized to
scatter raw materials [19], [20]. To guarantee thorough hydration, the mixture is then
held in a huge tank. Water-soluble minerals are dissolved in hot water separately and
then added to the mixture. With the addition of alkali or citric acid solution, the pH
of the mixture can be changed [21]. When oil-soluble vitamins are needed in the
mix, they are first dissolved in oil before being added to the oil mix tank. The oilsoluble vitamins are premixed and added to the final storage tank before being dried
or mixed with the spray-dried powder if they are encapsulated. Regardless of
whether batch or continuous processing is used, the pipes and tank should be flushed

with compressed air at least once a day, and the mixing line should be cleaned in situ
(CIP) at least once a day [10]. The lactose content of raw materials is particularly
crucial for hydration since it preserves the original structure of proteins after drying.
Lactose, after all, is a somewhat insoluble sugar. As a result, there is a critical dry
matter concentration at which lactose is no longer soluble during the wet-mixing of
powdered infant formula [16].

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2.2.2. Homogenisation and emulsification:
During the wet-mixing of powdered infant formula, fat stabilization is critical
to avoid separation. Proteins are amphiphilic molecules with both hydrophobic and
hydrophilic areas that play a key role in the emulsification of powdered infant
formula. Fat is broken down into little globules during homogenization and
stabilized by proteins that absorb at the fat-water interface. Hydrophobic sections of
adsorbed proteins are oriented toward the fat phase, while hydrophilic areas are
oriented toward the aqueous phase. Furthermore, powdered infant formula,
especially powdered infant formula containing hydrolyzed proteins, may contain
low molecular weight surfactants that act as emulsifiers. Surfactants, like proteins,
have hydrophobic areas that soak in the fat-water interface and hydrophilic sections
that are in touch with the aqueous phase [16].
2.2.3. Heat treatment:
Heat treatment is an important control point for powdered infant formula's
microbiological purity. Heat treatment can be placed at any point in the process.
Because aggregates of fat globules formed during heat treatment [22] may be

disrupted by homogenisation, it may be desirable to position the heat treatment
before homogenisation to produce a more stable emulsion [21]. McCarthy et al.
[19],[20] used heat treatment before homogenization in their research.
2.2.4. Evaporation:
To remove water from powdered infant formula wet-mixes before spray
drying, evaporation is commonly used. Evaporation can remove water at a lower
cost of energy than spray drying [23]. The dairy business frequently uses falling film
evaporators. The wet-mix flows by gravity through a series of tubes during falling
film evaporation, producing a film on the inside of each tube as it descends. The
outside of the tubes is sprayed with live steam, which causes the water in the wet8

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mix to evaporate. Evaporation takes place in a vacuum (50 to 70 °C), which permits
heat-sensitive wet-mixes to evaporate. The amount of concentration that may be
achieved is determined by viscosity increase; post-evaporation viscosity of whole
milk should not exceed 603100 mPa.s for efficient drying [24]. Evaporation can
impact the physical condition of wet-mix elements in addition to viscosity changes.
Liu et al. (2012) found that micellar hydration, aggregation, and the amount of
calcium associated with the micelle were all altered by the concentration of skim
milk [25]. During evaporation, calcium phosphate is transferred from a soluble to a
colloidal micellar form, which lowers pH. During evaporation, McCarthy et al.
noticed an increase in the size of fat globules in IMF emulsions [20].
2.2.5. Spray drying:
Spray drying is used to make powdered infant formula. Wet-mixes that have
been atomised into fine droplets (103400 μm) to improve the area of contact with
the hot air is removed with hot air [24]. Spray dryers with two or three stages are

commonly used to make powdered infant formula. Spray drying in two or three
stages comprises a large drying chamber (stage 1) in which the majority of the water
is removed, followed by supplemental drying utilizing an internal fluidised bed
(stage 2) and/or exterior fluidised bed (stage 3). Powder particle agglomeration is
used to improve the wettability and flowability of powdered baby formula. Random
collisions of atomized particles during drying will cause spontaneous agglomeration
of powder particles. The atomised particles from two or more atomising machines
are positioned so that they overlap in forced primary aggregation. Fine particles that
depart the dryer's exhaust air and external fluid bed are reintroduced to the drying
chamber in forced secondary agglomeration [26].

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2.2.6. Packaging:
The powder is recirculated back into the main chamber or to a different point
in the process depending on the product type [27]. Depending on the type of product,
the powder agglomerates are either broken down to the desired size in a sifter or
milled after leaving the dryer. The final product is transferred from the spray drying
step to a silo using a positive pressure dense phase transport system [28], [24]. The
product is then transferred from the bottom of the silo to a blending section, where
it is blended with other powders and/or vacuum delivered to the filling line. Finally,
the product is gravity-fed into a hopper and transferred to the bagging or metal can
filling processes [10]. To prevent the oxidation of milk fat and polyunsaturated fatty
acids like docosahexaenoic acid (DHA), the final infant formula powder is always
packaged in a N environment [10].

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3. Cronobacter illnesses linked to powdered infant formula
3.1. Cronobacter sakazakii
The Cronobacter genus is composed of Gram-negative, facultative anaerobic
rods which are members of the Enterobacteriaceae family and closely related to the
genera Enterobacter and Citrobacter [9]. The genus Cronobacter was originally
defined and created by reclassifying the species Enterobacter sakazakii [9]. It
belongs to the taxonomic class Gammaproteobacteria and the family
Enterobacteriaceae [9].
It consists of facultatively anaerobic, Gram-negative, oxidase-negative,
catalase-positive, non-spore forming rods that are generally motile, capable of
reducing nitrate to nitrite, producing acetoin, and failing the methyl red test [9].
Following the initial proposal of the Cronobacter genus, three additional taxonomic
revisions have occurred, and the genus now consists of seven species: C. sakazakii,
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C. malonaticus, C. turicensis, C. universalis, C. muytjensii, C. dublinensis, and C.
condimenti [29] [30] [31].

Figure 3. Seven species of Cronobacter genus [9]

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Cronobacter sakazakii [32]

Domain: Bacteria
Phylum: Pseudomonodota
Class: Gammaproteobacteria
Order: Enterobacterales
Family: Enterobacteriaceae
Genus: Cronobacter
Species: C. sakazakii
Cronobacter sakazakii, previously known as Enterobacter sakazakii [30]
[33], is an opportunistic Gram-negative, rod-shaped pathogenic bacterium that can
live in extremely dry environments, known as xerotolerance. C. sakazakii survives
desiccation by utilizing several genes [34], and this xerotolerance may be strainspecific [35].
Cronobacter sakazakii was first isolated from a can of dried milk in 1950,
even though these organisms have most likely existed for millions of years [32].
Over the next few decades, E. sakazakii was linked to dozens of cases of infant
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meningitis and sepsis, often in conjunction with powdered infant formula [32].
Although adults account for the vast majority of C. sakazakii cases, low-birth-weight
preterm neonates and older infants are particularly vulnerable [32]. The pathogen is

a rare cause of invasive infection in infants, with historically high case fatality rates
(40380%) [32]. Around 50 percent of infants who have Cronobacter sakazakii die,
and those who survive may experience neurological impairment [36].
According to the Centers for Disease Control and Prevention and in the
literature all cases of bloodstream infection or meningitis among infants were
reported (196132018; n = 183) [37]. Most infants were neonates (100/150 [67%]);
38% (42/112) died, and 79% (81/102) had reported recent PIF consumption [37].
Table 2. Numbers of reported invasive Cronobacter infections among infants, by
country, 1961-2018 [37].

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In the final quarter of the study period (200432018), case counts were
significantly higher (global average 8.7 cases/year); among US cases, significantly
higher proportions occurred among full-term (56% [27/48]) and nonhospitalized
(78% [42/54]) infants [37].
All Cronobacter species, except C. condimenti, have been linked
retrospectively to clinical cases of infection in either adults or infants [32]. However,
multilocus sequence typing [38] has revealed that the majority of neonatal
meningitis cases in the last 30 years have been linked to only one genetic lineage of
the species Cronobacter sakazakii known as 'Sequence Type 4' or 'ST4', [39] and
thus this clone appears to be of greatest concern with infant infections.

Figure 4. Sources of C.sakazakii strains [9]
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Symptoms of Cronobacter Infection [36]
Cronobacter symptoms usually include the following in infants:


Poor feeding response



Irritability



Jaundice



Grunting while breathing



Unstable body temperature

A Cronobacter sakazakii infection can also turn into meningitis, an inflammation of
the membranes surrounding the brain and spinal cord. Signs of meningitis in

newborns include:


High fever



Constant crying



Excessive sleepiness or irritability



Sluggishness



Poor feeding



A bulge in the soft spot on the top of the head



Stiffness of the body and neck



Seizures

Cases of Cronobacter sakazakii contamination in other products

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Most neonatal C. sakazakii infections cases have been associated with the use
of powdered infant formula [40] [41] with some strains able to survive in a
desiccated state for more than two years[42]. However, not all cases have been
linked to contaminated infant formula [32]. In November 2011, several shipments
of Kotex tampons were recalled due to a Cronobacter (E. sakazakii) contamination
[32]. In one study, the pathogen was found in 12% of field vegetables and 13% of
hydroponic vegetables [43] [44].
3.2. Some reported cases of Cronobacter spp. infections related to powdered
infant formula (PIF)
Cronobacter spp. (formerly Enterobacter sakazakii) infection is rare but can
kill 40%380% of infected infants[41]. The first two documented cases of
Cronobacter species occurred in 1958 at St. Albans, England[45]. According to the
Centers for Disease Control and Prevention (CDC) [46] and FAO/WHO [7], from
1958 to 2009, there was 120 cases of Cronobacter infection in infants have been
reported, and at least 27 deaths from all parts of the world.
The below table is the summary of some outbreaks and cases of Cronobacter
species until 2017, according to Song et al. in 2018[45].
Table 3. Outbreaks and cases of infections

Location
St. Albans, England

Year
1958

Cease/Death
2/2

References
Urmenyi and Franklin, 1961

Denmark
Macon, GA, USA

1965
1979

Joker et al., 1965
Monroe and Tift, 1979

Indianapolis, IN, USA
The Netherlands

1981
1983

1/None
1/Not
mentioned

1/None
8/None

Athens, Greece

1985

Reykjavik, Iceland

1986-1987

1/Not
mentioned
3/1

Kleiman et al., 1981
Muytjens et al., 1983; Muytjens,
1985; Muytjens and Kollee, 1990
Arseni et al., 1985
Biering et al., 1989; Clark et al.,
1990

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Boston, MA, and New

Orleans, LA, USA
Memphis, TN, USA

1987

Willis and Robinson, 1988

1993, 1995,
1997,1998
1995/1996
1998
2000

2/Not
mentioned
4/Not
mentioned
1/Not
mentioned
1/Not
mentioned
4/Not
mentioned
5/4
12/2
1/None

Baltimore, MD, USA

1990

Cincinnati, OH, USA

1990

Israel

1997-2000

5/None

Knoxville, TN, USA
Tennessee, USA
Wisconsin, USA

2001
2002
2002

USA

2003

France

2004

USA

2004

USA

2005

Canada

2007

New Mexico, USA
Queretaro, Mexico
Florida, Illinois,
Missouri, and Oklahoma,
USA
Not mentioned
China

2008
2010
2011

10/1
1/1
1/Not
mentioned
6/Not
mentioned
2/Not
mentioned
2/Not

mentioned
2/Not
mentioned
2/Not
mentioned
2/None
2/None
4/2

Block et al., 2002; Bar-Oz B et al.,
2001
Himelright et al., 2002; Weir, 2002
CDC, 2002
CDC unpublished data, Bowen and
Barden, 2006
CDC unpublished data; Bowen and
Barden, 2006
Coignard et al., 2004; Bowen and
Barden, 2006
CDC unpublished data; Bowen and
Barden, 2006
CDC unpublished data; Bowen and
Barden, 2006
Pagotto and Farber, 2009

2012
2017

1/None
2/1

Boston, MA, USA
Belgium
Winston Salem, NC,
USA
Israel

1988

Simmons et al., 1989
Noriega et al., 1990
Gallagher and Ball, 1991
Block et al., 2002
Lai, 2001
Van Acker et al., 2001
Burdette and Santos, 2000

CDC, 2009
Flores et al., 2011
CDC, 2012

Broge and Lee, 2013
Cui et al., 2017

As can be seen, there are several reported cases of Cronobacter infection in
neonates and infants. However, before 1994, C. sakazakii was not identified as a
substantial source of newborn infection, and its relationship with PIF had not yet
been established. Since then, contaminated PIF has been recognized as the primary
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risk factor for neonatal Cronobacter spp. infections in a plethora of published papers
and research[4]. Below are some cases that have been associated with a powdered
infant:
o

For 8 cases in the Netherlands, there was the first description of

an association between Cronobacter spp. and infant milk formula reported by
Muytjens et al. in 1983[47] [48]. It was said that these cases might have been
caused by inadequate hygiene or contamination of powdered infant formula
due to improper handling methods.
o

In Belgium, the out outbreak involved 12 infants and resulted in

the death of twin brothers. The infant formula powder that was used to feed
the infants was stopped temporarily until further tests were carried out. After
the initial analysis indicated that the formula powder was not contaminated,
there was a resumption of the use of the product. However, these preliminary
tests were incorrect, but this was discovered only when a female child suffered
Cronobacter-associated necrotizing enterocolitis. The research of Van Acker
et al in 2001[49] showed that C. sakazakii was isolated from both the
implicated prepared formula milk and numerous unopened cans from the
single batch. Further investigations found that the manufacturer's quality
control regime concerning coliforms did not comply with Belgian legislation,

and all and all contaminated products were ultimately recalled[48].
o

In the United Stage, many cases of Cronobacter infection were

also reported. In 1989, the outbreak in a hospital in Memphis involved four
infants that of who had been fed with the same infant formula prepared in the
same food blender. Cronobacter spp. at 8 CFU/100 g and E. cloacae at 48
CFU/100 g were found in the powdered infant formula[50]. The food blender
was also contaminated with Cronobacter spp., Pseudomonas fluorescens, and
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Pseudomonas maltophil. The outbreak was said may have originated at the
food blender[48]. In 2001, there was the first report of C. sakazakii infection
associated with infant formula prompting the recall of a commercial product
in the United States[40]. In this case, a cohort analysis was conducted on the
49 patients who were evaluated to identify potential risk factors for C.
sakazakii infection or colonization. There were nine case patients and forty
noncase individuals among the 49 patients found in the cohort. The research
pointed to specific infant formula as the cause of the infection, and testing on
both open and unopened cans of the infant formula was positive for
Cronobacter spp.
o

In 2007, the case that Cronobacter spp. was identified as the

cause of meningitis in a 17-day-old infant in Canada was linked to powdered
infant formula. In addition, in the same year, in India the first two cases of
Cronobacter spp. infection was documented. Powdered infant formula was
suspected of being the source of infection for at least one of the babies,
although the pathogen was not isolated from the formula due to a lack of
testing[48].
In particular, most recently, in 2022, there were four cases of illness believed
to be linked to powdered milk. This incident was initially believed to be related to
Abbott Laboratories which is a United State health care company well-known for
many nutrition brands such as Pedialyte, Ensure, Glucerna, and Similac. Especially
Similac is one of the famous baby formula infants that most parents choose for their
children. According to the statistical data in 2020, there were 3.18 million consumers
in the U.S[14]. There were, however, four customer complaints involving
Cronobacter sakazakii or Salmonella Newport in infants who had taken powder

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baby formula prepared in this plant. Below are some more detailed descriptions of
this Abbott9s recall:
o

Abbott voluntarily recalled Similac, Alimentum, and EleCare

products made in Sturgis, Michigan on February 17, 2022. This action follows

after four consumer reports of Cronobacter sakazakii or Salmonella Newport
in children who had taken powder infant formula processed in this plant[51].
o

According to FDA, during testing in Sturgis, Michigan facility,

they found evidence of Cronobacter sakazakii in the plant in non-product
contact areas but no evidence of Salmonella Newport. Besides, the retained
samples related to the four complaints about Cronobacter sakazakii, and
Salmonella Newport had negative results for all samples. Nevertheless, it
cannot be denied that there have been 4 cases of infants who consumed
formula produced at this facility infected with Cronobacter[51]. More
investigations were taking place at this time.
o Consumers were also advised not to use recalled Similac, Alimentum,
or EleCare by FDA.[52]:

Figure 5. Recall for Similac, Alimentum, and EleCare powdered infant formulas

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Products are included in the recall if they have all three items
below[52]:
- The first two digits of the code are 22 through 37 and
- The code on the container contains K8, SH, or Z2, and
- The expiration date is 4-1-2022 (APR 2022) or later.

Figure 6. Recall products have a code beginning from 22 to 37 and containing
K8, SH, or Z2

o

On February 28, 2022, Abbott continue volunteer recalled one

lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case))
manufactured in Sturgis, Michigan. The action is being taken in response to
the death of a child who tested positive for Cronobacter sakazakii and was
said to have drunk Similac PM 60/40 from this batch.

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