Drug recall
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended…
FDA recall event 67757 · Class II · Aspen Surgical Products, Inc.
Key facts
| Event ID | 67757 |
|---|---|
| Recall numbers | Z-1417-2014, Z-1418-2014, Z-1419-2014, Z-1420-2014, Z-1421-2014, Z-1422-2014, Z-1423-2014, Z-1424-2014, Z-1425-2014, Z-1426-2014, Z-1427-2014, Z-1428-2014 and 7 more |
| Recalling firm | Aspen Surgical Products, Inc. |
| Product type | Devices |
| Products | 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage, 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage, 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage, 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage, 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage and 14 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. |
| Initiation date | Mar 20, 2014 |
| Report date | Apr 16, 2014 |
| Termination date | Nov 25, 2014 |
| City | Caledonia |
| State | MI |
| Country | United States |
| FEI number | 3002750084 |
At a glance
- 10–99 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: