Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding)
Summary
The FDA issued a Class II for Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feed by Abbott Laboratories. Reason: Potential leaking/pinholes in bottle.
Details
Source
Food Recall
External ID
F-1575-2022
Action Date
2022-08-31
Status
Terminated
Category
food
Product Description
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
Lot/Code Info: 41819RN00 Expiration Date: 06/01/23
Quantity Affected: 179 cases (1,432 bottles)
Reason for Recall
Potential leaking/pinholes in bottle
Distribution
Distributed to consignees in MD, NY, AL, FL, MA, NJ, and MI
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-03
Company
Altavista, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1575-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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