Medline sterile convenience kits recalled due to weak breather pouch seals
Medline is recalling certain sterile convenience kits packaged with breather pouches that may have open or weak seals. Approximately 14,760 units were distributed worldwide.
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 an FDA Class II recall of medical device packaging. No illnesses or injuries have been reported. However, the potential for compromised seals on sterile product packaging represents a risk-of-harm product where injury has not yet been reported, meeting the High severity threshold per the rubric.
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits due to a potential issue with breather pouches used for packaging. The breather pouches may have open or weak seals.
Approximately 14,760 units have been distributed worldwide, including the United States, Canada, Mexico, Panama, and the Virgin Islands. The affected products are identified by multiple product codes and lot numbers.
This FDA Class II recall was initiated based on the potential for open or weak seals on the packaging breather pouches used in select sterile convenience kits.
The recalled product
- Product
- Refer to RES
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- 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) DYNJ84990
- UDI-DI: 10195327444068(each)
- 40195327444069(case)
- Lot Number: 24IBE926
- 2) DYNJ45711B
- UDI-DI: 10193489856149(each)
- 40193489856140(case)
- Lot Number: 24IBE981
- 3) DYNJ45266B
- UDI-DI: 10193489852417(each)
- 40193489852418(case)
- Lot Number: 24IBF031
- 4) DYNJ80737B
- UDI-DI: 10198459050855(each)
- 40198459050856(case)
- Lot Number: 24IBF165
- 5) DYNJ67785A
- UDI-DI: 10193489945638(each)
- 40193489945639(case)
- Lot Number: 24IBG441
Distribution
Distributed nationwide across the United States.
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