Medline sterile convenience kits recalled for potential weak breather pouch seals
Medline Industries is recalling ten models of sterile convenience kits used for various medical procedures due to potential open or weak seals on breather pouches. The seal failure could compromise sterility 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: This is a Class II recall of sterile medical devices where compromised packaging seals create a risk of contamination and loss of sterility. The source text presents a potential hazard (open/weak seals) without reporting actual illness or injury, which per the rubric qualifies as High (score 3).
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits distributed worldwide, including in the US, Canada, Mexico, Panama, and the US Virgin Islands. The recalled kits include ten models used for procedures such as biopsies, phlebectomy, drainage, and sperm extraction. The recall was initiated due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile kits.
The affected kits are: 1) LARGE BIOPSY PACK NTX (Model DYNJ68393A, Lot 24IBP745); 2) SOFT TISSUE BIOPSY PACK (Model DYNJ81441B, Lot 24JBB770); 3) BILAT TESTICULAR SPERM EXTRACT (Model DYNJ68303, Lot 24JBU406); 4) PROCEDURE MINEURE BJC-LF (Models DYNJ41678B, Lots 24JBW438 and 24JBW452); 5) PHLEBECTOMY PACK (Model DYNJ55215G, Lot 24KBC666); 6) BIOPSY/DRAINAGE TRAY-LF (Model DYNJ30078D, Lot 24KBD430); 7) CAT BIOPSY PACK (Model DYNJ62968, Lot 24KBE699); 8) ABLATION/DRAINAGE PACK (Model DYNJ53658D, Lot 24KBF023); and 9) BIOPSY KIT (Model DYNJ61130B, Lot 24KBG714). A total of 1,126 units have been identified.
Healthcare facilities and providers should stop using affected kits immediately and check their inventory against the provided lot numbers and model numbers. Facilities should contact Medline Industries for guidance on proper handling and replacement of the recalled kits.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-defect
- 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) DYNJ68393A
- UDI-DI: 10193489939996(each)
- 40193489939997(case)
- Lot Number: 24IBP745
- 2) DYNJ81441B
- UDI-DI: 10198459111105(each)
- 40198459111106(case)
- Lot Number: 24JBB770
- 3) DYNJ68303
- UDI-DI: 10193489821529(each)
- 40193489821520(case)
- Lot Number: 24JBU406
- 4) DYNJ41678B
- UDI-DI: 10198459124129(each)
- 40198459124120(case)
- Lot Number: 24JBW438
- 5) DYNJ41678B
- Lot Number: 24JBW452
- 6) DYNJ55215G
- UDI-DI: 10193489925555(each)
Distribution
Distributed nationwide across the United States.
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