Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0740-03

Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202

Boston Scientific Corporation / initiated 2003-03-17 / Terminated

Boston Scientific Corporation began a recall of Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202 on . The reason FDA records is "Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0740-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202
Product code
GBM Catheter, Urethral
Reason for recall
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
FDA root cause
Other
Action
Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.
Quantity in commerce
72 boxes (20 units/box)
Distribution
Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
Product codes and lots
Lot Numbers: 5161012 5174860 5174861 5180481 5185487 5218431 5221729 5243192 5243192 5252957 5296861 5296862 5303657 5327920 5327921 5327921 5345290 5348157 5355947