FDA Enforcement
Class II
Terminated
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.
Recall: Z-2558-2014
·
Reported September 3, 2014
Enforcement
- Recall Number
- Z-2558-2014
- Event ID
- 68951
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Civco Medical Instruments Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 3, 2014
- Initiation Date
- August 1, 2014
- Classification Date
- August 28, 2014
- Termination Date
- January 28, 2015
- Address
- 102 1st St S, N/A, Kalona, IA, 52247-9589, United States
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
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Code Info
Lot numbers: M431760, M431710, M426580, M430200, M423010
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.
Quantity
52 kits