Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0699-05

BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7...

Wilson-Cook Medical Inc. / initiated 2005-04-01 / Terminated / root cause: labeling and UDI

Wilson-Cook Medical Inc began a recall of 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... on . The reason FDA records is "The expiration date listed on the product label is greater than the vendor recommended expiration date". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0699-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wilson-Cook Medical Inc.
Product
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.
Product code
GCJ Laparoscope, General & Plastic Surgery
Reason for recall
The expiration date listed on the product label is greater than the vendor recommended expiration date.
Root cause tag
labeling and UDI
FDA root cause
Labeling False and Misleading
Action
Consignees were notified by certified mail on 04/01/2005.
Quantity in commerce
18 units
Distribution
Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan
Product codes and lots
Product Order #BCP-7A: Lot #1331630, Vendor Exp. Date 01/2005 * Label Exp. Date 02/2005