Recall Z-1162-2007
Cook Urological, Inc. · initiated June 12, 2007
Product
Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
Codes / lots: Lot U1621121
Reason for recall
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
FDA-determined cause: Process control
Action taken
Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.
Details
- Recall number
- Z-1162-2007
- Initiated
- June 12, 2007
- Posted by FDA
- August 9, 2007
- Terminated
- November 25, 2009
- Product code
- EZB – Stylet For Catheter, Gastro-Urology
- Quantity
- 100
- Distribution
- Nationwide and Canada.
- Recalling firm
- Cook Urological, Inc., Spencer, IN