FDA-Device2014-04-16Class II
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Aspen Surgical Products, Inc.
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.
Sold states
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.
Affected count
N/A
Manufactured in
6945 Southbelt Dr Se, N/A, Caledonia, MI, United States
Products
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1422-2014Don't want to check this manually?
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