Recall Z-1435-2014— Aspen Surgical Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Aspen Surgical Products, Inc., initiated 2014-03-20, terminated 2014-11-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case). Reason: 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..
- Recalling firm
- Aspen Surgical Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-20
- Terminated
- 2014-11-25
- Firm location
- Caledonia, MI, United States
Product description
7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.