Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1880-2009

Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P)

Bard Peripheral Vascular Inc / initiated 2009-03-26 / Terminated / root cause: manufacturing process

Bard Peripheral Vas began a recall of Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P) on . The reason FDA records is "Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1880-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bard Peripheral Vascular Inc
Product
Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P).
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall
Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.
Quantity in commerce
750
Distribution
Worldwide Distribution.
Product codes and lots
Lot Numbers: HUSE0106, HUSG0392, HUSG0608, HUSH0853 and HUSH1534.