Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
This recall has been terminated (originally issued February 22, 2007).
- Company
- Cook Endoscopy
- Recall Initiated
- January 24, 2007
- Posted
- February 22, 2007
- Terminated
- July 26, 2012
- Recall Number
- Z-0520-2007
- Quantity
- 12 units
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
Distribution
Worldwide, including NY and TX in USA, Australia, Canada and India.
Lot / Code Info
Order number QBD-10X3, Lot number W2287708
Root Cause
Other
Action Taken
Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
More recalls by Cook Endoscopy
Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical
Product Usage: This...
Jun 28, 2011
DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 2710...
Jan 19, 2011
DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-...
Jan 19, 2011