# K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Jun 30, 2004 after 328 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 26 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003245 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011283: Monoject Prefill 0.9% Sodium Chloride Flush Syringe, The Kendall Company (2001) Summary page 1.
- K013556: Monoject Prefill Heparin Lock Flush Syringe, Tyco Healthcare (2001) Summary page 1.

## Most influential descendants
- K090882: Flush Syringe Filled with 0.9% Sodium Chloride (2010), 0 descendants of its own
- K060339: Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery (2006), 0 descendants of its own

## Recalls of this device
- Aug 19, 2021 · Class I · Z-0119-2022: Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the s
- Aug 4, 2021 · Class I · Z-2284-2021: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Aug 4, 2021 · Class I · Z-2286-2021: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Aug 4, 2021 · Class I · Z-2285-2021: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Aug 16, 2013 · Class II · Z-2178-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2185-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2184-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2183-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2182-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2186-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2180-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2179-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Aug 16, 2013 · Class II · Z-2181-2013: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
- Nov 15, 2010 · Not classified · Z-0564-2011: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Nov 15, 2010 · Not classified · Z-0566-2011: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Nov 15, 2010 · Not classified · Z-0567-2011: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Nov 15, 2010 · Not classified · Z-0568-2011: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Nov 15, 2010 · Not classified · Z-0565-2011: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Nov 15, 2010 · Not classified · Z-0569-2011: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Mar 28, 2008 · Not classified · Z-1595-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Mar 28, 2008 · Not classified · Z-1602-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Mar 28, 2008 · Not classified · Z-1600-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Mar 28, 2008 · Not classified · Z-1598-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Mar 28, 2008 · Not classified · Z-1597-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant Tyco Healthcare, Mansfield, MA 02048
- Mar 28, 2008 · Not classified · Z-1599-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Mar 28, 2008 · Not classified · Z-1596-2008: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant

## Indications for use
The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Source page: https://510kreport.com/device/K032438
Methodology: https://510kreport.com/methodology