# K171957: MaxZero Extension Sets with Needless Connector

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 303, Inc.
- Decided: Jul 19, 2017 after 20 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942988 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140831: Maxzero Extension Set with Needless Connector, Care Fusion (2014) Summary page 4.

## Recalls of this device
- Apr 24, 2019 · Class II · Z-0082-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0083-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0096-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0099-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0105-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0075-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0076-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0078-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0080-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0084-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0089-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0090-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0093-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0094-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0098-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0103-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0106-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0077-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0088-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0097-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0079-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0081-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0100-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0101-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0102-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0085-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0107-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0086-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0087-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0091-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0092-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0095-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 24, 2019 · Class II · Z-0104-2020: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the conne
- Apr 10, 2019 · Class II · Z-0284-2020: BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.

## Indications for use
Pressure Rated: The MaxZero™ Extension Set with Needle-Free Connector(s) is for single use only. The MaxZero™ Extension Set with Needle-Free Connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.

Source page: https://510kreport.com/device/K171957
Methodology: https://510kreport.com/methodology