Drug recall
Cascade Autologous Platelet System Rx Distributed by ConMed Linvatec 11311 Concept Boulevard Largo, Florida…
FDA recall event 66045 · Class I · Musculoskeletal Transplant Foundation
Key facts
| Event ID | 66045 |
|---|---|
| Recall numbers | B-0103-14 |
| Recalling firm | Musculoskeletal Transplant Foundation |
| Product type | Biologics |
| Products | Cascade Autologous Platelet System Rx Distributed by ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Manufactured by: MTF Musculoskeletal Transplant Foundation 125 May Street Edison… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A single lot of CASCADE Autologous Platelet System, containing a component (yellow tube) that may have higher than normal endotoxin levels, was distributed. |
| Initiation date | Jul 30, 2013 |
| Report date | Jan 22, 2014 |
| Termination date | Jan 13, 2015 |
| City | Edison |
| State | NJ |
| Country | United States |
| FEI number | 3001236616 |
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: