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Aspen Surgical Products, Inc. recalls 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound sucti
Recalled April 16, 2014 · FDA recall Z-1417-2014 · Aspen Surgical Products
Hazard
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. · FDA Class II
Units
N/A
Sold at
Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Description
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.
Product
7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Manufacturer(s)
Aspen Surgical Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →