Recall Z-0510-06 ยท FFL Dislodger, Stone, Basket, Ureteral, Metal
Boston Scientific Corp
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.
| Date | Feb 8, 2006 (initiated Dec 20, 2005) |
| Status | Terminated |
| Reason | The basket wire assembly may detach from the drive wire while in the patient. |
| Root cause | Other |
| Action | U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their customers. |
| Quantity | 2076 |
| Distribution | Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, South Korea, Singapore, South Africa, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.