Medline sterile convenience kits recalled for potential weak breather pouch seals
Medline is recalling sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. Seal failure could compromise the sterile integrity of the kits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—open or weak seals on sterile device packaging—represents a potential risk of contamination and loss of sterile integrity, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries is recalling select sterile convenience kits (Model DYNJ0371999G, Lot 24KBE129) used for various medical procedures. The affected kits contain breather pouches with a potential for open or weak seals.
The defective seals on breather pouches could compromise the sterile integrity of the convenience kits, potentially allowing contamination of the sterile field or products.
The affected kits were distributed worldwide, including to the United States, Canada, Mexico, Panama, and the Virgin Islands. A total of 8 units were identified in this recall.
Healthcare providers and facilities that have received these kits should stop using them and contact Medline Industries for replacement or credit. Consult the manufacturer's recall instructions for proper handling of unused kits.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) DYNJ0371999G
- UDI-DI: 10889942061037(each)
- 40889942061038(case)
- Lot Number: 24KBE129
Distribution
Distributed nationwide across the United States.
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