FDA Recall
Terminated
BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable Single Use Only * Sterile/EO * Rx Only * Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Recall: Z-0699-05
·
Initiated April 1, 2005
Recall
- Recall Number
- Z-0699-05
- Event Number
- 31553
- Firm
- Wilson-Cook Medical Inc
- FEI Number
- 1037905
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- April 1, 2005
- Posted
- April 8, 2005
- Terminated
- July 8, 2005
- Address
- 5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206
Description
BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable Single Use Only * Sterile/EO * Rx Only * Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Reason
The expiration date listed on the product label is greater than the vendor recommended expiration date.
Action
Consignees were notified by certified mail on 04/01/2005.
Distribution
Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan
Quantity
18 units