Drug recall
Terumo BCT Lake wood, CO 80215, Catalog No 61000 Spectra Optima Apheresis System, Country of Origin: US.
FDA recall event 68784 · Class III · Terumo BCT, Inc.
Key facts
| Event ID | 68784 |
|---|---|
| Recall numbers | B-0994-14 |
| Recalling firm | Terumo BCT, Inc. |
| Product type | Biologics |
| Products | Terumo BCT Lake wood, CO 80215, Catalog No 61000 Spectra Optima Apheresis System, Country of Origin: US. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Spectra Optia Apheresis Systems Return Line Air Detector (RLAD) Sensors, associated with component failure which may disrupt or end an ongoing apheresis procedure, were distributed. |
| Initiation date | Aug 4, 2014 |
| Report date | Oct 1, 2014 |
| Termination date | May 2, 2016 |
| City | Lakewood |
| State | CO |
| Country | United States |
| FEI number | 1000117351 |
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: