Drug recall
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has…
FDA recall event 73261 · Class III · Medtronic Perfusion Systems
Key facts
| Event ID | 73261 |
|---|---|
| Recall numbers | Z-1023-2016 |
| Recalling firm | Medtronic Perfusion Systems |
| Product type | Devices |
| Products | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems… |
| Initiation date | Feb 4, 2016 |
| Report date | Mar 9, 2016 |
| Termination date | Nov 7, 2016 |
| City | Brooklyn Park |
| State | MN |
| Country | United States |
| FEI number | 1000116158 |
At a glance
- 1–9 Products in this recall
- 10–99 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: