Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling sterile convenience kits with select breather pouches that may have open or weak seals, potentially compromising sterility. Affected units were distributed worldwide, including the US, 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 a FDA Class II recall of sterile medical devices where breached sterility integrity poses a risk of harm (infection or contamination). No illnesses or injuries have been reported, but the hazard—compromised sterility of medical products—is directly tied to patient safety and meets the High severity threshold for risk-of-harm products without reported adverse events.
Plain-English summary
Medline Industries, LP is recalling 11,889 units of sterile convenience kits due to a potential for open or weak seals on purchased breather pouches used for packaging these kits. Open or weak seals on breather pouches may compromise the sterility of the packaged products.
The affected sterile convenience kits were distributed worldwide, including distribution to the United States, Canada, Mexico, Panama, and the Virgin Islands. The recall encompasses multiple product variants identified by specific lot numbers and UDI codes.
Customers who have purchased affected sterile convenience kits should discontinue use and contact Medline Industries, LP for further instructions regarding the recalled products.
The recalled product
- Product
- Refer to RES
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-breach
- seal-defect
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 (20)
- 1) DYNJ61594
- UDI-DI: 10193489586121(each)
- 40193489586122(case)
- Lot Number: 24IBF062
- 2) DYNJ31798D
- UDI-DI: 10195327609078(each)
- 40195327609079(case)
- Lot Number: 24IBF219
- 3) DYNJ46311F
- UDI-DI: 10193489933185(each)
- 40193489933186(case)
- Lot Number: 24IBF751
- 4) DYNJ49386A
- UDI-DI: 10889942292882(each)
- 40889942292883(case)
- Lot Number: 24IBF768
- 5) DYNJ51781G
- UDI-DI: 10198459045974(each)
- 40198459045975(case)
- Lot Number: 24IBG614
Distribution
Distributed nationwide across the United States.
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