Device 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.
Z-2558-2014
Product summary
- Event
- Event 68951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52 kits
- Official record key
device-enforcement:Z-2558-2014
Official wording
Reason: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Code information: Lot numbers: M431760, M431710, M426580, M430200, M423010
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.
Derived failure modes
-
Sterility assurance
packaging of the recalled product potentially could compromise the sterility