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Normal Saline IV Flush Syringe
MEDEFIL, INC. · Model 3mL in 12mL Syringe · UDI-DI 30364253111335
NGT
Prescription
1
510(k) clearances
3,171
Adverse events (23 deaths)
61
Recalls
50
Facilities
Description
Medefil Normal Saline IV Flush Syringe, 3mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-06 | Spectra Medical Devices, Llc | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganism |
| 2025-09-11 | Medline Industries, LP | Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. |
| 2023-12-28 | MRP, LLC dba Aquabiliti | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months. |
| 2023-11-16 | Becton Dickinson & Company | An 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 Flush Syringes with |
| 2023-11-06 | Nurse Assist, LLC | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in |
| 2023-11-06 | Nurse Assist, LLC | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-03-04 | MEDLINE INDUSTRIES, LP - Northfield | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field. |
| 2021-08-19 | Windstone 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 expelled and reintroduce |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.