Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOST
Pending LLM rewrite. Source: FDA_DEVICE Z-1385-2026.
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 STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
- 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) DYKMBNDL55
- UDI-DI: 10193489478839(each)
- 40193489478830(case)
- Lot Number: 21FBA766
- 2) DYKMBNDL55
- Lot Number: 21DBB713
- 3) DYKMBNDL55
- Lot Number: 21CBH955
- 4) DYKMBNDL55
- Lot Number: 21ABX057
- 5) DYKMBNDL55
- Lot Number: 21ABK325
- 6) DYKMBNDL55A
- UDI-DI: 10193489897890(each)
- 40193489897891(case)
- Lot Number: 23CBN841
- 7) DYKMBNDL55A
- Lot Number: 22LBK911
- 8) DYKMBNDL55A
- Lot Number: 22KBH787
Distribution
Distributed nationwide across the United States.
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