Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHE
Pending LLM rewrite. Source: FDA_DEVICE Z-1384-2026.
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) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
- 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) DYNJ0185290G
- UDI-DI: 10193489378054(each)
- 40193489378055(case)
- Lot Number: 22LBQ336
- 2) DYNJ905567A
- UDI-DI: 10193489348927(each)
- 40193489348928(case)
- Lot Number: 24BBN429
- 3) DYNJ905567A
- Lot Number: 23KBI089
- 4) DYNJ905567A
- Lot Number: 23HBG596
- 5) DYNJ905567A
- Lot Number: 23FBL644
- 6) DYNJ905567A
- Lot Number: 23FBG152
- 7) DYNJ905567A
- Lot Number: 23EBH550
- 8) DYNJ905567A
- Lot Number: 23CBQ546
Distribution
Distributed nationwide across the United States.
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