Z-0049-2020Class II

CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless...

Name: Z-0049-2020 CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless...
Creator: Becton Dickinson & Company
Published: 2019-05-02
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-05-02 / Terminated

FDA source

Becton Dickinson & Company began a recall of CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV... on 2019-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0049-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Posted: 2019-10-07
Terminated: 2021-11-30
Recalling firm: Becton Dickinson & Co
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
Product code: FPA Set, Administration, Intravascular
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.
FDA root cause: Under Investigation by 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)
Quantity in commerce: 115,200
Distribution: Nationwide Foreign: Canada
Product codes and lots: Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0049-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0049-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code FPA

K083472Class IIMedegen Pressure Rated Extension SetsMedegen, Inc. / cleared 2008-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)