Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-1404-2026.
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) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
- 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 (12)
- 1) DYNJ15668R
- UDI-DI: 10195327108502(each)
- 40195327108503(case)
- Lot Number: 23HMB037
- 2) DYNJ42829B
- UDI-DI: 10193489880151(each)
- 40193489880152(case)
- Lot Number: 22IBI084
- 3) DYNJT3437
- UDI-DI: 10198459325076(each)
- 40198459325077(case)
- Lot Number: 25FBK633
Distribution
Distributed nationwide across the United States.
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