Drug recall
Haemonetics MCS+ 8150 Apheresis System-Automated Blood Cell Separator Catalog number: 08150-110-XX…
FDA recall event 72815 · Class III · Haemonetics Corporation
Key facts
| Event ID | 72815 |
|---|---|
| Recall numbers | B-0346-16, B-0347-16, B-0348-16, B-0349-16 |
| Recalling firm | Haemonetics Corporation |
| Product type | Biologics |
| Products | Haemonetics MCS+ 8150 Apheresis System-Automated Blood Cell Separator Catalog number: 08150-110-XX, 08150-220-XX, Haemonetics MCS+ 9000 Apheresis System-Automated Cell Separator Catalog number: 09000-110-XX, 09000-220-XX, Haemonetics Model 215 Automated Glycerolization/Deglycerolization System List number: 02215-110-XX, 02215-220-XX, Haemonetics PCS2 Plasma Collection System-Automated Blood Cell Separator. Catalog Numbers:06002-CP-110, 06002-CP-220-XX, 06002-CPL-110, 06002-110-XX-XX, 06002-220-XX |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Haemonetics' Rotor Cleaning Updated User Manual Addendum was distributed. |
| Initiation date | Dec 4, 2015 |
| Report date | Mar 9, 2016 |
| Termination date | Apr 15, 2016 |
| 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: