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Terminated

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog Number: MOO513330 The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). Single packaged units of M00513330 are not sold individually.

FDA Recall Z-1774-2010 · Posted 2010-06-04

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFCL
Date Initiated2010-05-06
Date Terminated2011-09-20

Reason for Recall

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

Firm Action

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

Distribution Pattern

Nationwide; Panama.

Official Source

View FDA Recall →

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

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