Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK
Pending LLM rewrite. Source: FDA_DEVICE Z-1388-2026.
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) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
- 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) DYKE1743
- UDI-DI: 10193489294606(each)
- 40193489294607(case)
- Lot Number: 23KBQ544
- 2) DYKE1743
- Lot Number: 23JBO193
- 3) DYNJ0800934D
- UDI-DI: 10193489398885(each)
- 40193489398886(case)
- Lot Number: 21EBQ851
- 4) DYNJ0800934D
- Lot Number: 21DBA951
- 5) DYNJ0800934D
- Lot Number: 21BKA527
- 6) DYNJ0800934D
- Lot Number: 21AKB217
- 7) DYNJ0842873J
- UDI-DI: 10193489448917(each)
- 40193489448918(case)
- Lot Number: 21ADA204
Distribution
Distributed nationwide across the United States.
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