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Terminated

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

FDA Recall Z-0118-2008 · Posted 2007-10-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFFF
Date Initiated2007-08-28
Date Terminated2008-07-10
Product Quantity734 boxes

Reason for Recall

Device lacked manufacturing finishing process resulting in endoscope damage.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide, including USA, Sweden, and South Africa.

Official Source

View FDA Recall →

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

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