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Terminated

Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.

FDA Recall Z-0510-06 · Posted 2006-02-08

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeFFL
Date Initiated2005-12-20
Date Terminated2007-05-01
Product Quantity2076

Reason for Recall

The basket wire assembly may detach from the drive wire while in the patient.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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