Symbiosis Corp.
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.
| Date | Feb 21, 2003 (initiated Sep 3, 2002) |
| Status | Terminated |
| Reason | Product does not have the needle component as part of the jaw assembly. |
| 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 | 155/5-pack |
| Distribution | Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.