| | Class 2 Device Recall Captura Serrated Large Forcep |  |
| Date Initiated by Firm | December 18, 2018 |
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| Create Date | January 25, 2019 |
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| Recall Status1 |
Terminated 3 on December 14, 2020 |
| Recall Number | Z-0775-2019 |
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| Recall Event ID |
81875 |
| Product Classification |
Cover, biopsy forceps - Product Code FFF
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| Product | COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S |
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| Code Information |
Lot Number W4035257 |
Recalling Firm/
Manufacturer |
Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203
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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). |
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FDA Determined
Cause 2 | Error in labeling |
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| 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. |
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| Quantity in Commerce | 6 units |
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| Distribution | France, Ireland, Japan |
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| Total Product Life Cycle | TPLC Device Report |
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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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