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Recall Observatory FDA recall evidence

Device product

PEDIATRIC IV & IV START KIT

Z-1092-2018

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-1092-2018

Official wording

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

Code information: IV5785 IV6135 Lot codes: 2015121890 2016031490 2016102490 2016111490 2017012390 2017050890 2016071190 2015101990 2015120790 2016010490 2016012590 2016101090 2017010290 2017061990 2017071090

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.