Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model
Pending LLM rewrite. Source: FDA_DEVICE Z-1390-2026.
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) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
- 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) CDS840015AQ
- UDI-DI: 10195327210144(each)
- 40195327210145(case)
- Lot Number: 23FLA191
- 2) CDS840023T
- UDI-DI: 10193489682069(each)
- 40193489682060(case)
- Lot Number: 23LBM199
- 3) CDS840023T
- Lot Number: 23KBM369
- 4) CDS840023T
- Lot Number: 23JBU616
- 5) CDS840023T
- Lot Number: 23IBJ759
- 6) CDS840023T
- Lot Number: 23IBJ571
- 7) CDS840023T
- Lot Number: 23GBA105
- 8) CDS840023T
- Lot Number: 23CBO830
Distribution
Distributed nationwide across the United States.
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