FDAFDA · Food and drugs·Recall number Z-2107-2020
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)
Published June 3, 2020 · Recall initiated: December 17, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Quest Medical, Inc.
- Distributor
- US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
- Lot
- Lot Number: 059135
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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