Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, M
Pending LLM rewrite. Source: FDA_DEVICE Z-1414-2026.
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) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
- 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) DYKM2326
- UDI-DI: 10198459565748(each)
- 40198459565749(case)
- Lot Number: 25KMF765
- 2) DYKMBNDL165
- UDI-DI: 10193489477405(each)
- 40193489477406(case)
- Lot Number: 24ABK386
- 3) DYKMBNDL165
- Lot Number: 23KBV905
- 4) DYKMBNDL165
- Lot Number: 23KBA329
- 5) DYKMBNDL165
- Lot Number: 23HBR548
- 6) DYKMBNDL165
- Lot Number: 23EBP170
- 7) DYKMBNDL165
- Lot Number: 23BBT994
- 8) DYKMBNDL165
- Lot Number: 22LBB693
Distribution
Distributed nationwide across the United States.
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