Medline Sterile Convenience Kits Recalled for Potentially Weak Breather Pouch Seals
Medline Industries is recalling 28,127 sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect could compromise product 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 an FDA Class II recall for sterile medical device packaging with potential seal defects. No illnesses or injuries have been reported. The classification reflects the risk-of-harm posed by potential sterility compromise on a sealed sterile product, consistent with the rubric's criteria for High severity when injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 28,127 units of sterile convenience kits distributed worldwide. The products incorporate breather pouches for packaging.
The recall is due to a potential for open or weak seals on the purchased breather pouches. Compromised seals could allow the loss of product sterility during storage and distribution.
The affected kits were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. Specific product codes, lot numbers, and UDI identifiers for all affected units are listed on the FDA's official recall notice.
Consumers and healthcare providers with affected units should stop use and contact their healthcare provider or Medline Industries for instructions on replacement or return.
The recalled product
- Product
- Refer to RES
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-compromise
- 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) DYNJHTLD02A
- UDI-DI: 10193489303360(each)
- 40193489303361(case)
- Lot Number: 24IBE784
- 2) DYNJ50017B
- UDI-DI: 10889942851126(each)
- 40889942851127(case)
- Lot Number: 24IBE809
- 3) DYNJ68242C
- UDI-DI: 10198459091568(each)
- 40198459091569(case)
- Lot Number: 24IBF050
- 4) SYNJ10001B
- UDI-DI: 10195327067977(each)
- 40195327067978(case)
- Lot Number: 24IBF241
- 5) DYNJ42691
- UDI-DI: 10888277003507(each)
- 40888277003508(case)
- Lot Number: 24IBF320
Distribution
Distributed nationwide across the United States.
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