FDA Recall Terminated

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

Recall: Z-0049-2020 · Initiated May 2, 2019

Recall

Recall Number
Z-0049-2020
Event Number
82970
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
FPA
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
May 2, 2019
Terminated
November 30, 2021
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

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

Reason

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.

Action

BD MDS (Medication Delivery Solutions) initiated communication to US on May 2, 2019 via Fed'X. Letter states product defect, health risk and action to take:1. Immediately review for the specific Catalogue (Ref) and lot numbers . Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Regional Customer Quality 888-237-2762 OPT 3, OPT 2 Monday Friday between the hours of 8:00am and 5:00pm (CST)

Distribution

Nationwide Foreign: Canada

Quantity

115,200