DMject Insulin Syringe
Shinchang Medical Co., Ltd. · Model DMject Insulin Syringe 0.5mL 30G×5/16" · UDI-DI 08800109007076
Description
1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Instructions for use 1) To expose plunger, remove large orange cap. 2) To expose needle, pull small orange cap STRAIGHT off, being careful not to bend needle. 3) To measure correct dosage align top edge of plunger tip with your dosage mark on the syringe scale. 4) Use syringe ONCE only. To prevent misuse after injection, destroy syringe and needle. 4. Warning For patients who mix two types of insulin, do not change (a) the order of mixing that the physician has prescribed or (b) the model and brand of the syringe without first consulting your physician or pharmacist. Failure to heed this warning can result in dosage error. 5. Storage Avoid direct sunlight and store at room temperature in a dry and clean place. 6. Caution Federal law restricts this device to sale by or on the order of a physician. 7. Expiry Date : 5 years from manufacturing date
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-28 | Mentor Texas LP | A single lot of expired syringes were distributed due to a distribution system control failure. |
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2026-02-27 | Cardinal Health 200, LLC | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages |
| 2026-01-27 | Becton Dickinson & Company | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. |
| 2025-05-23 | Integra LifeSciences Corp. (NeuroSciences) | Lack of sterility assurance. |
| 2025-05-22 | Integra LifeSciences Corp. (NeuroSciences) | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. |
| 2025-05-22 | Integra LifeSciences Corp. (NeuroSciences) | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. |
| 2025-05-22 | Integra LifeSciences Corp. (NeuroSciences) | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. |
| 2025-05-12 | BD SWITZERLAND SARL | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the |
| 2025-05-12 | BD SWITZERLAND SARL | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the |
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