Class IITerminated · reported 2022-08-31

Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding…

Abbott Laboratories recalled this product and the FDA reported the enforcement action on 31 August 2022 as Class II. The recall was initiated by the firm. Potential leaking/pinholes in bottle

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681
UPC: 700746268162681
Reason for recall: Potential leaking/pinholes in bottle
Recalling firm: Abbott Laboratories
Firm location: Altavista, Virginia, United States
Classification: Class II
Status: Terminated
Recall number: F-1575-2022
Quantity: 179 cases (1,432 bottles)
Distribution: Distributed to consignees in MD, NY, AL, FL, MA, NJ, and MI
Initiated: 3 July 2022
Reported by FDA: 31 August 2022
Terminated: 9 June 2023
Firm notified by: Telephone
Product codes: 41819RN00 Expiration Date: 06/01/23

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 11 months, from 3 July 2022 to termination on 9 June 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The distribution pattern names 6 states, and the FDA published the enforcement report 8 weeks after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Named in the distribution pattern: New York, Alabama, Florida, Massachusetts, New Jersey, Michigan. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from Abbott Laboratories

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 60 other records name this firm.

Reported	Product	Firm	Reason	Class
2023-11-15	Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.	Abbott Laboratories	Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive	Class II
2023-04-19	Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton	Abbott Laboratories	Potential of foreign material (hard plastic) within product	Class II
2022-11-23	Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II
2022-11-23	Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton	Abbott Laboratories	Compromised seal integrity which could lead to spoilage	Class II

All 61 records for Abbott Laboratories

All 2022 recalls · All FDA food recall data

Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.