Recalls / —

—#27967

Product

Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog no. 372403

510(k) numbers

K955293

Affected lot / code info

Lot Number: 5473831

Why it was recalled

Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Place, Natick, Massachusetts 01760

Distribution

Distribution pattern

Japan, Italy, France, Turkey, Israel, Finland

Timeline

Recall initiated

2003-06-23

Posted by FDA

2003-07-19

Terminated

2018-10-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27967. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.