FDA Device recall 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…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of 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… by Quest Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2107-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-17 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Quest Medical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Number: 059135 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2020%22
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