Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Pending LLM rewrite. Source: FDA_DEVICE Z-1410-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
The recalled product
- Product
- Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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) DYKA1343A
- UDI-DI: 10193489312966(each)
- 40193489312967(case)
- Lot Number: 25LBC732
- 2) DYKA1343A
- Lot Number: 25FBN781
- 3) DYKA1343A
- Lot Number: 25DBK346
- 4) DYKA1343A
- Lot Number: 24IBD021
- 5) DYKA1343A
- Lot Number: 24DBK171
- 6) DYKA1343A
- Lot Number: 24BBV821
- 7) DYKA1343A
- Lot Number: 23HBP415
- 8) DYKA1343A
- Lot Number: 23EBC552
- 9) DYKA1343A
- Lot Number: 23CBE825
Distribution
Distributed nationwide across the United States.
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