Drug recall
800-0501 Plasmax Plasma Concentrator with GPS Mini and 50mL ACD-A
FDA recall event 37512 · Class II · Biomet, Inc.
Key facts
| Event ID | 37512 |
|---|---|
| Recall numbers | B-1269-07, B-1270-07, B-1271-07, B-1272-07, B-1273-07, B-1274-07, B-1275-07, B-1276-07, B-1277-07, B-1278-07 |
| Recalling firm | Biomet, Inc. |
| Product type | Biologics |
| Products | 800-0501 Plasmax Plasma Concentrator with GPS Mini and 50mL ACD-A, 800-0503A GPS Mini Platelet Concentrate Separation Kit with 30mL ACD-A, 800-0504A GPS Mini Platelet Concentrate Separation Kit with 50ML ACD-A, 800-0515 Plasmax Plus Plasma Concentrator with GPS II and 50ML ACD-A, 800-0621A GPS II Double Unit with Syringes 30mL ACD-A and 5 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Autologous blood processing devices, with a potential lack of assurance of sterility, were distributed. |
| Initiation date | Mar 5, 2007 |
| Termination date | Dec 5, 2007 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 10–99 Products in this recall
- None 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