Medline Convenience Kits Recalled for Potential Weak Seals
Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.
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: This is an FDA Class II recall involving sterile medical device kits with potential packaging seal failures that could compromise sterility. While no reported illnesses or injuries are stated in the source, the risk-of-harm scenario—compromised sterile packaging on devices used for procedures—justifies a High severity rating per the rubric.
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits because of a potential for open or weak seals on the purchased breather pouches used for packaging. The recalled products include the T&A ENDO PACK (Model DYNJ59620A, Lot 24KBH321) and the TRAY ADD A CATH FOL UM MF 10ML (Model DYND150200S, Lot 24KBK308). A total of 530 units have been distributed.
The kits have been distributed nationwide in the United States and internationally to Canada, Mexico, Panama, and the Virgin Islands. Healthcare facilities and providers who have received these products should verify the integrity of the breather pouches before use. Patients or healthcare professionals who have concerns about these products should contact Medline Industries.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-compromise
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 (8)
- 1) DYNJ59620A
- UDI-DI: 10193489685367(each)
- 40193489685368(case)
- Lot Number: 24KBH321
- 2) DYND150200S
- UDI-DI: 10195327387884(each)
- 40195327387885(case)
- Lot Number: 24KBK308
Distribution
Distributed nationwide across the United States.
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