Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog Number: MOO513330 The Radial Jaw 4 Lar

FDA device recall Z-1774-2010 · posted 2010-06-04 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

FCL

Distribution

Nationwide; Panama.

Date initiated

2010-05-06

Date posted

2010-06-04

Date terminated

2011-09-20

Location

Marlborough, MA