Class 2 Device Recall Captura Serrated Forceps with Spike

• Date Initiated by Firm: December 18, 2018
• Create Date: January 25, 2019
• Recall Status: Terminated on December 14, 2020
• Recall Number: Z-0774-2019
• Recall Event ID: 81875
• Product Classification: Cover, biopsy forceps - Product Code FFF
• Product: COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
• Code Information: Lot Number W4035256
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc.; 4900 Bethania Station Rd; Winston Salem NC 27105-1203
• Manufacturer 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).
• FDA Determined Cause: Error in labeling
• 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.
• Quantity in Commerce: 8 units
• Distribution: France, Ireland, Japan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.