Recall Z-1422-2014— 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: Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems. 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
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
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.