Drug recall
Spectra Optia Exchange Set (Catalog/REF 10220), Batch: 2005043130
FDA recall event 86644 · Class III · Terumo BCT, Inc.
Key facts
| Event ID | 86644 |
|---|---|
| Recall numbers | B-0043-2021 |
| Recalling firm | Terumo BCT, Inc. |
| Product type | Biologics |
| Products | Spectra Optia Exchange Set (Catalog/REF 10220), Batch: 2005043130 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Terumo Blood and Cell Technologies' Spectra Optia Aheresis System with mislabeled disposable tubing sets, were distributed. |
| Initiation date | Oct 26, 2020 |
| Report date | Nov 25, 2020 |
| Termination date | Apr 19, 2021 |
| 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: