Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Pending LLM rewrite. Source: FDA_DEVICE Z-1408-2026.
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) PPE KIT, Model Number: DYK1011945P
- 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) DYK1011945P
- UDI-DI: 10884389389973(each)
- 40884389389974(case)
- Lot Number: 25IFA006
- 2) DYK1011945P
- Lot Number: 24GFA027
- 3) DYK1011945P
- Lot Number: 24FFA115
- 4) DYK1011945P
- Lot Number: 24BFA115
- 5) DYK1011945P
- Lot Number: 23LFA050
- 6) DYK1011945P
- Lot Number: 23GFA079
- 7) DYK1011945P
- Lot Number: 23EFA070
- 8) DYK1011945P
- Lot Number: 23EFA007
- 9) DYK1011945P
- Lot Number: 23DFA024
Distribution
Distributed nationwide across the United States.
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