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Saline, Vascular Access Flush

FDA product code NGT · Class 2 · General Hospital

191
Registered devices
3,148
Adverse events
61
Recalls
40
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-07-06Spectra Medical Devices, LlcManufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be expo
2025-09-11Medline Industries, LPMedline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
2023-12-28MRP, LLC dba AquabilitiThe saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
2023-11-16Becton Dickinson & CompanyAn incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled
2023-11-06Nurse Assist, LLCSodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh
2023-11-06Nurse Assist, LLCSodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
2022-03-04MEDLINE INDUSTRIES, LP - NorthfieldSterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
2021-08-19Windstone Medical Packaging, Inc.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 expe

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.