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Recall Observatory FDA recall evidence

Device product

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

Z-0966-2019

December 20, 2018

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 82019
Status
Terminated
Classification
Class II
Quantity
12 packs
Official record key
device-enforcement:Z-0966-2019

Official wording

Reason: Presence of natural rubber latex is not declared in the label

Code information: Lot Numbers: V A30

Distribution pattern: TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Presence of natural rubber latex is not declared in the label