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Recall Observatory FDA recall evidence

Device product

Bentson Plus Wire Guide

Z-0952-2018

October 13, 2017

Class II

Product summary

Firm
Cook Inc.
Event
Event 79195
Status
Terminated
Classification
Class II
Quantity
8,147
Official record key
device-enforcement:Z-0952-2018

Official wording

Reason: Label does not state that the product is heparin-coated.

Code information: Catalog # TSFBP- / -BH Affected lots include: 3771080 - 5942053 F4265639

Distribution pattern: Nationally

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Label does not state