Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
This recall has been terminated (originally issued January 25, 2007).
- Company
- Cook Urological, Inc.
- Recall Initiated
- January 5, 2007
- Posted
- January 25, 2007
- Terminated
- May 1, 2008
- Recall Number
- Z-0377-2007
- Quantity
- 4
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility, as the packages may not have been sealed.
Distribution
Massachusetts, Maine, New Hampshire and Puerto Rico.
Lot / Code Info
Lot U1546391.
Root Cause
Other
Action Taken
Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
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