Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Ord
FDA device recall Z-1162-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Cook Urological, Inc.
- Reason for recall
- Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EZB
- Quantity affected
- 100
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-06-12
- Date posted
- 2007-08-09
- Date terminated
- 2009-11-25
- Location
- Spencer, IN
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