Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer,...
FDA Recall #Z-1100-2023 — Class II — December 23, 2022
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.
Recalling Firm
Quest Medical, Inc. — Allen, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
13,900
Distribution
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)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated