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.
This recall has been terminated (originally issued August 9, 2007).
- Company
- Cook Urological, Inc.
- Recall Initiated
- June 12, 2007
- Posted
- August 9, 2007
- Terminated
- November 25, 2009
- Recall Number
- Z-1162-2007
- Quantity
- 100
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
Distribution
Nationwide and Canada.
Lot / Code Info
Lot U1621121
Root 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.
More recalls by Cook Urological, Inc.
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Jan 25, 2007