Reported Jun 3, 2020 · Terminated
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The…
Quest Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quest Medical, Inc. · 1 Allentown Pkwy · Allen, TX · 75002-4206
Is this the product you have?
Ref 801168MPS Top Cover Replacement Kit1 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)
- Lot codes and dates
- Lot Number059135
- Amount recalled
- 5 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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