Quest Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2107-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: December 17, 2019

Date Posted: June 3, 2020

Recall Number: Z-2107-2020

Event ID: 85389

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.

Status: Terminated

Product Quantity: 5 units

Code Information:

Lot Number: 059135

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated