Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ref 801168 Recalled by Quest Medical, Inc. Due to Additive and Arrest Agent Labels on the MPS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Quest Medical, Inc. directly.
Affected Products
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)
Quantity: 5 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Quest Medical, Inc.
Quest Medical, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report