Drug recall
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver…
FDA recall event 79031 · Class II · Haemonetics Corporation
Key facts
| Event ID | 79031 |
|---|---|
| Recall numbers | Z-0778-2019, Z-0779-2019 |
| Recalling firm | Haemonetics Corporation |
| Product type | Devices |
| Products | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery…, Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. |
| Initiation date | Aug 2, 2017 |
| Report date | Feb 6, 2019 |
| Termination date | Aug 6, 2020 |
| City | Braintree |
| State | MA |
| Country | United States |
| FEI number | 1219343 |
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: