Select Sterile Convenience Kits Recalled Due to Weak Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches. The affected packaging 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: This is a Class II recall of sterile medical device packaging. Open or weak seals on breather pouches create a risk-of-harm scenario by potentially compromising sterility. No illnesses or injuries have been reported to date; the hazard is theoretical. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
Medline Industries, LP (Northfield) is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The recall affects 11,889 units with distribution in the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands.
Breather pouches with open or weak seals could compromise the sterile packaging. This could potentially expose the sterile medical devices to contamination.
Affected healthcare providers and distributors should stop using the recalled products. Users should check their inventory against the lot numbers and product codes provided by the FDA and Medline Industries for detailed identification of affected units.
The recalled product
- Product
- Refer to RES
- 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) 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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