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Recall Observatory FDA recall evidence

Device product

STERILE CAP CHANGE KIT DYNDC1946B

Z-0086-2020

April 24, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 83584
Status
Terminated
Classification
Class II
Quantity
181965 total
Official record key
device-enforcement:Z-0086-2020

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: 2018101790 2018092790 2019030690

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.