Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0562-03

Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length...

Boston Scientific Corporation / initiated 2002-09-03 / Terminated

Symbiosis Corp. began a recall of Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is... on . The reason FDA records is "Product does not have the needle component as part of the jaw assembly". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0562-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box.
Reason for recall
Product does not have the needle component as part of the jaw assembly.
FDA root cause
Other
Action
The firm forwarded recall letters and response forms via Federal Express to Risk Managers at hospitals on 9/3/2002. Accounts were asked to return product by first calling 1-800-862-1284.
Quantity in commerce
155/5-pack
Distribution
Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
Product codes and lots
The code for the individual pouches is Catalog 1589 and Lot # 0551847, expiration date of 2005-07. The code for the five pack boxes is Catalog No. 1589 and lot number 0551847, expiration date of 2005-07.