Drug recall
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC…
FDA recall event 77482 · Class II · Mallinckrodt Manufacturing LLC
Key facts
| Event ID | 77482 |
|---|---|
| Recall numbers | Z-2687-2017 |
| Recalling firm | Mallinckrodt Manufacturing LLC |
| Product type | Devices |
| Products | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product was improperly labeled leading to improper storage. |
| Initiation date | Oct 17, 2014 |
| Report date | Jul 12, 2017 |
| Termination date | Jul 15, 2017 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 3006472186 |
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: