Sterile convenience kits recalled for potentially weak breather pouch seals
Medline Industries is recalling sterile convenience kits due to potential open or weak seals on breather pouches used in packaging. Defective seals may compromise product sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a packaging/seal defect on sterile medical device pouches that presents a potential for non-sterility; however, the source states only a "potential" for defect with no documented adverse health consequences reported.
Plain-English summary
Medline Industries, LP is recalling sterile convenience kits that contain purchased breather pouches with a potential for open or weak seals. Approximately 28,127 units have been affected. The breather pouches are used for packaging of select sterile convenience kits and are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
Defective or compromised seals on the breather pouches may allow the contents to become non-sterile during storage and handling. This could result in patient safety risks if the affected kits are used in clinical or healthcare settings.
Consumers and healthcare facilities should stop using affected units and contact Medline Industries with questions or to report any adverse events. Specific product codes and lot numbers affected are listed in the official FDA recall notice.
The recalled product
- Product
- Refer to RES
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 28,127
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.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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