Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT P
Pending LLM rewrite. Source: FDA_DEVICE Z-1401-2026.
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) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, M
- 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) DYKMBNDL130
- UDI-DI: 10193489479027(each)
- 40193489479028(case)
- Lot Number: 21BBB580
- 2) DYKMBNDL130
- Lot Number: 21ABJ543
- 3) DYKMBNDL130
- Lot Number: 21ABC197
- 4) DYKMBNDL130A
- UDI-DI: 10193489829594(each)
- 40193489829595(case)
- Lot Number: 22GLB021
- 5) DYKMBNDL130A
- Lot Number: 22GLA694
- 6) DYKMBNDL130A
- Lot Number: 22FLA745
- 7) DYKMBNDL130A
- Lot Number: 22ELA008
- 8) DYKMBNDL130A
- Lot Number: 22DLA407
Distribution
Distributed nationwide across the United States.
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