Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/C
Pending LLM rewrite. Source: FDA_DEVICE Z-1389-2026.
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) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
- 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) CDS985094F
- UDI-DI: 10195327657642(each)
- 40195327657643(case)
- Lot Number: 25AMG933
- 2) DYKMBNDL153
- UDI-DI: 10193489478440(each)
- 40193489478441(case)
- Lot Number: 22ABO093
- 3) DYKMBNDL153
- Lot Number: 21LBJ748
- 4) DYKMBNDL153
- Lot Number: 21BBG516
- 5) DYKMBNDL153
- Lot Number: 21ABI976
- 6) DYKMBNDL4A
- UDI-DI: 10193489904512(each)
- 40193489904513(case)
- Lot Number: 22ALA279
- 7) DYKMBNDL4A
- Lot Number: 21KLA100
Distribution
Distributed nationwide across the United States.
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