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U.S. Department of Health and Human Services

Class 2 Device Recall Captura Serrated Large Forcep

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  Class 2 Device Recall Captura Serrated Large Forcep see related information
Date Initiated by Firm December 18, 2018
Create Date January 25, 2019
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-0775-2019
Recall Event ID 81875
Product Classification Cover, biopsy forceps - Product Code FFF
Product COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
Code Information Lot Number W4035257
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 2		 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 6 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.
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