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Civco Medical Instruments Inc recalls CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954.
Recalled September 3, 2014 · FDA recall Z-2558-2014 · Civco Medical Instruments
Hazard
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. · FDA Class II
Units
52 kits
Sold at
Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
Description
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Product
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
Manufacturer(s)
Civco Medical Instruments Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →