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Recall Observatory FDA recall evidence

Device product

Femoral Artery Pressure Monitoring Set

Z-0966-2018

October 13, 2017

Class II

Product summary

Firm
Cook Inc.
Event
Event 79195
Status
Terminated
Classification
Class II
Quantity
266
Official record key
device-enforcement:Z-0966-2018

Official wording

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

Code information: Catalog # C-PMS-300-CHILDRENS-A- 032988 ALL LOTS

Distribution pattern: Nationally

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Label does not state