Z-2107-2020 Class II Terminated
FDA device recall Z-2107-2020 was initiated by Quest Medical, Inc. on December 17, 2019 and is designated Class II. 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 t… The recall status is terminated (terminated April 17, 2024). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- April 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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)
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.
Distribution Pattern
US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
Code Information
Lot Number: 059135