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.
FDA Recall Z-0562-03 · Posted 2003-02-21
Recalling FirmSymbiosis Corp.
Recall StatusTerminated
Date Initiated2002-09-03
Date Terminated2008-04-15
Product Quantity155/5-pack
Reason for Recall
Product does not have the needle component as part of the jaw assembly.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.