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Recall Observatory FDA recall evidence

Device product

PEDIATRIC PICC INSERTION TRAY CVI4450

Z-0076-2020

April 24, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 83584
Status
Terminated
Classification
Class II
Quantity
181965
Official record key
device-enforcement:Z-0076-2020

Official wording

Reason: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information: 2017122801 2018021601

Distribution pattern: Nationwide domestic distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.