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.
FDA Recall Z-2558-2014 · Posted 2014-08-28
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Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeKQT
Date Initiated2014-08-01
Date Terminated2015-01-28
Product Quantity52 kits
Reason for Recall
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Firm Action
Civco Medical Instrucments contacted customers by phone and sent an Urgent Medical Device Recall letter dated August 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return all the affected product. Customers were instructed to contact Customer Service at 319-248-6520 with any concerns or questions.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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