# K042061: 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe

- Pathway: 510(k) (Special)
- Applicant: Becton Dickinson
- Decided: Aug 26, 2004 after 24 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003553 (2001). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003553: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (2001) Summary page 1.

## Most influential descendants
- K121050: 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe (2013), 6 descendants of its own
- K141311: 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe (2014), 3 descendants of its own
- K161552: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (2017), 2 descendants of its own
- K153481: 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe (2016), 1 descendant of its own
- K250884: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (2025), 0 descendants of its own

## Recalls of this device
- Aug 25, 2014 · Class II · Z-0025-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0027-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0035-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0026-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0028-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0031-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0032-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0033-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0034-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0036-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0029-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0030-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Jul 25, 2014 · Class II · Z-2670-2014: Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.

## Indications for use
The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's).

Source page: https://510kreport.com/device/K042061
Methodology: https://510kreport.com/methodology