Recall Z-2558-2014— Civco Medical Instruments Inc
Class II · Terminated
Class II FDA medical device recall by Civco Medical Instruments Inc, initiated 2014-08-01, terminated 2015-01-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product..
- Recalling firm
- Civco Medical Instruments Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-01
- Terminated
- 2015-01-28
- Firm location
- Kalona, IA, United States
Product description
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.
Reason for recall
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.