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Halyard
OWENS & MINOR DISTRIBUTION, INC. · Model SS010 · UDI-DI 10885632389757
NGT
Prescription
1
510(k) clearances
3,148
Adverse events (22 deaths)
61
Recalls
50
Facilities
Description
Prefilled Syringe Saline Flush Intravenous 10ML PP Clear Not Made with Natural Rubber Latex Halyard
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.