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FDAFDA · Food and drugs·Recall number Z-0096-2020

CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355

Published October 16, 2019 · Recall initiated: April 24, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Centurion Medical Products Corporation
Distributor
Nationwide domestic distribution.
Lot
2018030250 2018072750 2018090450 2018091750 2018122650 2019011050 2019020450 2019031350 2019040150
Risk classification
Class II
Area (FDA)
device
Country
United States

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