Home / Recalls / Quest Medical, Inc. / Z-2107-2020

Z-2107-2020 Class II Terminated

Recalled by Quest Medical, Inc. — Allen, TX

Recall Details

Product Type
Devices
Report Date
June 3, 2020
Initiation Date
December 17, 2019
Termination Date
April 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

Reason for Recall

Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.

Distribution Pattern

US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None

Code Information

Lot Number: 059135

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-1100-2023 Class II — Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with (December 23, 2022)
  • 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)