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Recall Observatory FDA recall evidence

Device product

NEONATAL IV START KIT

Z-1095-2018

October 23, 2017

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 79329
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1095-2018

Official wording

Reason: Convenience Kit containing components to assist practitioner with IV placement and securement.

Code information: IVS425 Lot codes: 2016091290 2016082290

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Convenience Kit containing components to assist practitioner with IV placement and securement.