Drug recall
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913…
FDA recall event 85389 · Class II · Quest Medical, Inc.
Key facts
| Event ID | 85389 |
|---|---|
| Recall numbers | Z-2107-2020 |
| Recalling firm | Quest Medical, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 17, 2019 |
| Report date | Jun 3, 2020 |
| Termination date | Apr 17, 2024 |
| City | Allen |
| State | TX |
| Country | United States |
| FEI number | 3001665800 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: