Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-1398-2026.
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) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
- 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) DYNJ83185
- UDI-DI: 10195327247058(each)
- 40195327247059(case)
- Lot Number: 23FDC392
- 2) DYNJ83185
- Lot Number: 23CDB552
- 3) DYNJ83185
- Lot Number: 23CDA474
- 4) DYNJ83185
- Lot Number: 22LDA486
- 5) DYNJ83185A
- UDI-DI: 10195327468606(each)
- 40195327468607(case)
- Lot Number: 24KDB955
- 6) DYNJ83185A
- Lot Number: 24IDB525
- 7) DYNJ83185A
- Lot Number: 24GDB922
- 8) DYNJ83185A
- Lot Number: 24FDB302
Distribution
Distributed nationwide across the United States.
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