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FDA (Device enforcement)Recalled 2019-05-02closedclass ii

Becton Dickinson & Company: CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. N

Is my product affected?

CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C

  • UPC 10885403223228

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling the CareFusion MaxPlus Clear Needleless Connector, a device used to provide needleless access to IV lines and catheters during IV therapy. The recall affects 115,200 units with lot number 18085990 and an expiration date of August 15, 2023, distributed nationwide and in Canada.

The connector has a defect in which the valve may remain recessed and not fully close after a luer is disconnected, either temporarily or permanently. If the valve fails to close completely and this goes undetected, patients face risks of blood loss and air embolism, with particular concern for newborn patients. The manufacturer's record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.

Details from the source

Reason for recall: After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population. Distribution: Nationwide Foreign: Canada Quantity: 115,200 Lot/code info: Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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