MaxPlus recallZ-0049-2020 · Becton Dickinson & Company · initiated May 2, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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)
Recall details
- Recall number
- Z-0049-2020
- Status
- Terminated
- Initiated by the company
- May 2, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 115,200
- Product code
- FPA
- FDA submissions
- K083472
- Distribution
- Nationwide Foreign: Canada
Product 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
Code information (models, lots, serial numbers)
Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MaxPlus MP1000-CBD Switzerland Sàrl · Set, administration, intravascular1 recall265 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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