Recalls / —

—#91704

Product

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334

FDA product code

FCL — Forceps, Biopsy, Non-Electric

Device class

Class 1

Medical specialty

Gastroenterology, Urology

Affected lot / code info

Lots: 13361332, 13361334

Why it was recalled

Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.

Recalling firm

Firm

Boston Scientific Corporation

Address

100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern

Nationwide; Panama.

Timeline

Recall initiated

2010-05-06

Posted by FDA

2010-06-04

Terminated

2011-09-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #91704. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.