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