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Terminated

COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

FDA Recall Z-0774-2019 · Posted None

Recalling FirmWilson-Cook Medical Inc.
Recall StatusTerminated
Product CodeFFF
Date Initiated2018-12-18
Date Terminated2020-12-14
Product Quantity8 units

Reason for Recall

The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).

Firm Action

The firm initiated the recall by letter in Europe on 18-December-2018 and 20-December-2018. The notices were sent in Japan today, 21-December-2018. The letter requested recall to the user level and return of the affected product.

Root Cause

Error in labeling

Distribution Pattern

France, Ireland, Japan

Official Source

View FDA Recall →

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

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