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Recall Observatory FDA recall evidence

Device product

COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

Z-0775-2019

December 18, 2018

Class II

Product summary

Firm
Wilson-Cook Medical Inc.
Event
Event 81875
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0775-2019

Official wording

Reason: 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).

Code information: Lot Number W4035257

Distribution pattern: France, Ireland, Japan

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled