Home / Recalls / Quest Medical, Inc. / Z-1100-2023

Z-1100-2023 Class II Ongoing

Recalled by Quest Medical, Inc. — Allen, TX

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)

Other recalls by Quest Medical, Inc.

  • Z-0197-2024 Class II — Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogeni (July 14, 2023)
  • Z-2107-2020 Class II — Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (December 17, 2019)
  • Z-0361-2016 Class II — Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exch (October 28, 2015)
  • Z-1368-2015 Class II — LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmol (February 26, 2015)