FDA (Devices) recall action 83584
The FDA (Devices) publishes a recall like this one as 33 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 33 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Centurion Medical Products is recalling Triple Lumen CVC kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate from the sealed surface after disconnection.
Centurion Medical Products is recalling Triple Lumen Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products is recalling CVC bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.
Centurion Medical Products is recalling CAP CHANGE KIT DYNDC1496B because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products is recalling VANTEX 7FR, 16CM, 3L CVC Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.
Centurion Medical Products is recalling Central Line Bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the sealed surface.
Centurion Medical Products Corporation is recalling Sorbaview IV kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products is recalling CAP Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.