FDA Recall
Terminated
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.
Recall: Z-0562-03
·
Initiated September 3, 2002
Recall
- Recall Number
- Z-0562-03
- Event Number
- 25510
- Firm
- Symbiosis Corp.
- FEI Number
- 1051710
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 3, 2002
- Posted
- February 21, 2003
- Terminated
- April 15, 2008
- Address
- 8600 NW 41th Street, Miami, FL, 33166
Description
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
Product does not have the needle component as part of the jaw assembly.
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.
Distribution
Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
Quantity
155/5-pack