Why is not Cronobacter sakazakii reportable in more than one state in the US?
Why was the first illness on September 16, 2021, but the first recall not until February 20, 2022?
According to the CDC, on February 10, 2022, CDC was notified of FDA’s investigation of consumer complaints of infant illness related to products from Abbott Nutrition in Sturgis, Michigan. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. CDC and FDA are conducting additional laboratory testing and investigation to better understand these cases as well as any additional cases.
In September 2021, and FDA inspection uncovered several issues:
- Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become soiled or contaminated.
- You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
- An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
- You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
- You did not install a filter capable of retaining particles 0.5 micrometer or smaller when compressed gas is used at a product filling machine.
No recall was initiated.
From September 16, 2021, to January 5, 2022, CDC received reports of three Cronobacter cases in infants that were later found to be linked to FDA’s ongoing investigation. On February 16, 2022, CDC asked clinicians and state and local health departments to provide information on other cases of Cronobacter infection associated with infant formula from November 2020 through the present. Since then, CDC has identified one additional reported case of Cronobacter infection in an infant who consumed formula produced at this facility.
As of February 28, 2022:
- Four infants in Minnesota (1), Ohio (2), and Texas (1) consumed formula produced at the Sturgis, Michigan, facility before they got sick.
- These infants consumed formula that included Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.
- Cronobacter infections may have contributed to the death of two infants in Ohio.
CDC has received reports of more possible cases of Cronobacter illnesses in infants and is investigating to determine if these cases are linked to formula products produced at the Abbott Nutrition facility in Sturgis, Michigan. CDC is performing whole genome sequencing on Cronobacter bacteria isolated from available patient samples to compare them with the environmental samples taken at the facility to determine if there is any relation.
FDA reports one complaint of a Salmonella infection in an infant who was fed recalled formula. CDC’s routine outbreak surveillance has not detected an outbreak of Salmonella illnesses linked to this case reported to FDA or any other cases of Salmonella linked to recalled formula.
The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakii infection. FDA and CDC informed the firm of these findings and on February 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled. This particular lot of Similac PM 60/40 was distributed to the U.S. and Israel. If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.
The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package (see image below). Products are included in the recall if they have all three items below:
- 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.
In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.
The recall impacts Alimentum, EleCare, and Human Milk Fortifier for markets outside the U.S. No other Abbott Nutrition products distributed outside of the U.S. are affected by this recall. According to the firm, recalled products were distributed to the following countries/locations: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.
The FDA has noted that Cronobacter infection surveillance is not handled the same way as infection with more common foodborne pathogens, such as Salmonella or E. coli O157:H7. Cronobacter is not nationally notifiable and not reportable except in one state [shout out to Minnesota], which means doctors and labs are not required to report cases to their health department. Because Cronobacter is not a nationally notifiable pathogen, FDA relies on consumer complaints of illness sent to the Agency and on health care providers informing FDA directly about infants with Cronobacter infections. In addition, because Cronobacter is not nationally notifiable, whole genome sequencing (WGS) is rarely performed on these isolates.