Device product
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Z-1100-2023
Product summary
- Event
- Event 91409
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,900
- Official record key
device-enforcement:Z-1100-2023
Official wording
Reason: Delivery Sets may have tubing that could become detached that could result in patient infection.
Code information: REF/UDI-DI/Lots (Expiration Dates): PD06F/00634624911062/65824 (4/18/2025), 65826 (4/18/2025), 66069 (5/16/2025); PDT05CV2/00634624921412/66645 (7/11/2025)
Distribution pattern: US Nationwide distribution in the state of MA.
Derived failure modes
-
Unknown
Delivery Sets may have tubing that could become detached that could result in patient infection.