Drug recall
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit, Part No. 174027 - Product Usage: has…
FDA recall event 85689 · Class II · Covidien Llc
Key facts
| Event ID | 85689 |
|---|---|
| Recall numbers | Z-2252-2020, Z-2253-2020, Z-2254-2020, Z-2255-2020 |
| Recalling firm | Covidien Llc |
| Product type | Devices |
| Products | Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair…, Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair…, Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects…, Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed. |
| Initiation date | May 12, 2020 |
| Report date | Jun 10, 2020 |
| City | Mansfield |
| State | MA |
| Country | United States |
| FEI number | 1282497 |
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: