Quest Medical, Inc. recalls Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The de…

Recall date

December 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2107-2020

FDA classification

Class II

Brand / firm

Quest Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)