Medline Convenience Kits Recalled for Breather Pouch Seal Defects
Medline Industries is recalling select sterile surgical convenience kits due to potential weak or open seals on breather pouches. Compromised seals could allow contamination of sterile supplies.
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 of sterile surgical kits with potential packaging seal compromise. No illnesses or injuries have been reported. The hazard represents a theoretical risk of contamination and infection if seals are actually compromised, but with no documented incidents, the rubric limits this to score 3.
Plain-English summary
Medline Industries, LP is recalling select sterile surgical convenience kits due to potential open or weak seals on breather pouches used to package the products. The breather pouches are designed to maintain sterility during storage and transport. If seals are compromised, sterile contents may be exposed to contamination, which could pose a risk of infection if used in surgical procedures.
The recalled products include various C-section trays, emergency birth packs, surgical closure packs, and related add-on kits across 12 different model numbers. Approximately 1,098 units have been distributed worldwide, including throughout the United States and to Canada, Mexico, Panama, and the US Virgin Islands.
Healthcare facilities and providers should verify the lot numbers of affected kits against the provided recall notice and discontinue use of any matching inventory. Contact Medline Industries directly with questions about specific affected lots or for guidance on replacement products.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Mod
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- package-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 (20)
- 1) MNS13635A
- UDI-DI: 10653160994244(each)
- 40653160994245(case)
- Lot Number: 24IBH747
- 2) DYNJ81281
- UDI-DI: 10195327103620(each)
- 40195327103621(case)
- Lot Number: 24JBM309
- 3) OBK387M
- UDI-DI: 10889942686810(each)
- 40889942686811(case)
- Lot Number: 24JBM385
- 4) DYNJ81281
- Lot Number: 24JBM576
- 5) DYNJ40573A
- UDI-DI: 10888277988514(each)
- 40888277988515(case)
- Lot Number: 24JBM871
- 6) CDS983998C
- UDI-DI: 10193489776713(each)
Distribution
Distributed nationwide across the United States.
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