—#173255

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K083472
Affected lot / code info: Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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)

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Foreign: Canada

Timeline

Recall initiated: 2019-05-02
Terminated: 2021-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.