Medline Sterile Convenience Kits Recalled for Potential Weak Seals
Medline Industries is recalling multiple sterile surgical convenience kits because purchased breather pouches used in packaging may have open or weak seals, which could compromise sterility.
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 involving sterile medical devices used in surgery; compromised packaging seals could result in sterility loss and risk of infection, representing a significant risk of harm to patients, though no illnesses or injuries are reported in the source.
Plain-English summary
Medline Industries, LP is recalling 3,205 units of multiple sterile surgical convenience kits due to a potential for open or weak seals on purchased breather pouches used for packaging. The breather pouches are part of the kit packaging system for these products.
The affected kits include 37 different model numbers, such as the DR. KHAN CABG ADDS PACK, CARDIAC STERNAL PACK, PACEMAKER PACK, EP PACK, and VASCULAR PACK variants, among others. These kits have been distributed worldwide, including to the US nationwide and to Canada, Mexico, Panama, and the Virgin Islands.
Affected customers who have purchased these kits should stop using them and contact Medline Industries for instructions. Healthcare facilities should verify the integrity of packaging seals before using any of the recalled kits. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-
- 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 (20)
- 1) DYNJ59310D
- UDI-DI: 10195327402396(each)
- 40195327402397(case)
- Lot Number: 24IBB643
- 2) DYNJ32436A
- UDI-DI: 10884389686614(each)
- 40884389686615(case)
- Lot Number: 24IBG295
- 3) DYNJ35586G
- UDI-DI: 10193489663235(each)
- 40193489663236(case)
- Lot Number: 24IBG343
- 4) DYNJ55343B
- UDI-DI: 10195327478056(each)
- 40195327478057(case)
- Lot Number: 24IBG535
- 5) DYNJ55343B
- Lot Number: 24IBH248
- 6) DYNJ65027B
- UDI-DI: 10193489471991(each)
Distribution
Distributed nationwide across the United States.
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