Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTR
Pending LLM rewrite. Source: FDA_DEVICE Z-1391-2026.
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) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY
- 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) 00-401993O
- UDI-DI: 10195327517366(each)
- 40195327517367(case)
- Lot Number: 23KBH528
- 2) ACC010268B
- UDI-DI: 10889942197477(each)
- 40889942197478(case)
- Lot Number: 24DDA188
- 3) ACC010268B
- Lot Number: 23IDA297
- 4) ACC010268B
- Lot Number: 23GDB567
- 5) ACC010268B
- Lot Number: 23FDC048
- 6) ACC010268B
- Lot Number: 23DDB175
- 7) ACC010268B
- Lot Number: 23DDA455
- 8) ACC010268B
- Lot Number: 23BDB271
Distribution
Distributed nationwide across the United States.
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