—#64331

Product

Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40

FDA product code: FFF — Cover, Biopsy Forceps
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot Numbers: 8984687, 8984688, 8984689, 8990186, 9003394, 9003396, 9005718, 9005719, 9017283

Why it was recalled

Device lacked manufacturing finishing process resulting in endoscope damage.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide, including USA, Sweden, and South Africa.

Timeline

Recall initiated: 2007-08-28
Posted by FDA: 2007-10-31
Terminated: 2008-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64331. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.