COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE recalled over labeling errors

Recall date

December 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Wilson-Cook Medical Inc. recalls COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

Recall number

Z-0774-2019

FDA classification

Class II

Brand / firm

Wilson-Cook Medical Inc.

Sold / distributed

France, Ireland, Japan

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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