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 Recall Z-0049-2020 · Posted None
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFPA
Date Initiated2019-05-02
Date Terminated2021-11-30
Product Quantity115,200
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.
Firm 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)
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Foreign: Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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