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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

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
Recall Number Z-1422-2014
Classification Class II
Code Info Product Number 310101
Product Distributed Qty
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.

Event Detail

Event Id 67757
Product Type Devices
Status Ongoing
Recalling Firm Aspen Surgical Products, Inc.
City Caledonia
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-20
Initial Firm Notification of Consignee or Public
Distribution Pattern 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.