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Profi disposable syringe

Shinchang Medical Co., Ltd. · Model Profi disposable syringe 3mL 23G×1" · UDI-DI 08800109050416

FMF
1
510(k) clearances
53,081
Adverse events (66 deaths)
305
Recalls
545
Facilities

Description

1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body. 3. Instructions for use 1) Expose needle by removing needle cover. 2) Inject the fluid into syringe by pulling plunger 3) After injecting the injection fluid into the syringe, inject into disinfected area by pushing plunger. 4) After injecting the fluid into the affected area, withdraw the syringe from needle and dispose immediately("Do not reuse") 4. Warning 1) This product is single use device, therefore it must be disposed after its use 2) Do not reuse after suction the medicines. 3) Do not use individual packages that are opened or damaged because sterilization is not guaranteed. 4) Do not use damaged or bent needle before use. 5) Do not use the product when it finds foreign substances before use 6) To prevent secondary contamination, open the package before use. 7) Do not use the product except general injection purposes. 8) Do not attempt to close the needle cover after use. If you are pierced by contaminated needle, various infections can infected 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 : 3 years from manufacturing date

Recalls

DateFirmReason
2026-04-28Mentor Texas LPA single lot of expired syringes were distributed due to a distribution system control failure.
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, 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
2026-02-27Cardinal Health 200, LLCThe 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
2026-01-27Becton Dickinson & CompanyDuring the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
2025-05-23Integra LifeSciences Corp. (NeuroSciences)Lack of sterility assurance.
2025-05-22Integra LifeSciences Corp. (NeuroSciences)Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-22Integra LifeSciences Corp. (NeuroSciences)Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-22Integra LifeSciences Corp. (NeuroSciences)Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-12BD SWITZERLAND SARLSterile, 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
2025-05-12BD SWITZERLAND SARLSterile, 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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Data 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.