Recall Z-2558-2014 ยท KQT Evacuator, Gastro-Urology
Civco Medical Instruments Inc
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.
| Date | Aug 28, 2014 (initiated Aug 1, 2014) |
| Status | Terminated |
| Reason | A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. |
| Root cause | Packaging |
| 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. |
| Quantity | 52 kits |
| Distribution | Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.