Z-1100-2023 Class II Ongoing
FDA device recall Z-1100-2023 was initiated by Quest Medical, Inc. on December 23, 2022 and is designated Class II. Reason for recall: Delivery Sets may have tubing that could become detached that could result in patient infection. The recall status is ongoing. Affected quantity: 13,900.
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2023
- Initiation Date
- December 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,900
Product Description
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Reason for Recall
Delivery Sets may have tubing that could become detached that could result in patient infection.
Distribution Pattern
US Nationwide distribution in the state of MA.
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)