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Terminated

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331

FDA Recall Z-1772-2010 · Posted 2010-06-04

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFCL
Date Initiated2010-05-06
Date Terminated2011-09-20
Product Quantity320 units

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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