Drug recall
SurCord(product code 0420) = 2.0cc, SurCord (product code 0410) = 1.0cc
FDA recall event 91988 · Class II · SURGENEX LLC
Key facts
| Event ID | 91988 |
|---|---|
| Recall numbers | B-0592-2023, B-0593-2023, B-0594-2023 |
| Recalling firm | SURGENEX LLC |
| Product type | Biologics |
| Products | SurCord(product code 0420) = 2.0cc, SurCord (product code 0410) = 1.0cc, SurFactor Acellular Amniotic Allograft (product code 0305)= 0.5cc, SurFactor Acellular Amniotic Allograft (product code 0310) = 1.0cc, SurFactor Acellular Amniotic Allograft (product code 0320) = 2.0…, SurForce (product code 0105) = 0.5 cc, SurForce (product code 0110) = 1.0 cc, SurForce (product code 0120) = 2.0 cc |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Surgenex is recalling SurForce, SurCord and SurFactor allografts because the firm received a warning letter from the FDA which referenced the products were distributed without an approved IND (or BLA)… |
| Initiation date | Dec 28, 2021 |
| Report date | Aug 30, 2023 |
| Termination date | Aug 25, 2023 |
| City | Scottsdale |
| State | AZ |
| Country | United States |
| FEI number | 3011692533 |
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: