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ONE-CARE TB Safety Syringes
MediVena, LLC · Model ONE-CARE TB Safety Syringes, 1mL, 27G x 0.5'' · UDI-DI 00810008214138
10
510(k) clearances
2,965
Adverse events
17
Recalls
139
Facilities
Description
ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of dosing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-25 | Cardinal Health 200, LLC | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (I |
| 2022-06-10 | Guangdong Haiou Medical Apparatus Co., Ltd | Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resultin |
| 2022-06-10 | Guangdong Haiou Medical Apparatus Co., Ltd | Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resultin |
| 2021-05-17 | Smiths Medical ASD Inc. | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approx |
| 2015-11-23 | Terumo Medical Corp | Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield). |
| 2013-07-10 | Smiths Medical ASD, Inc. | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| 2013-07-10 | Smiths Medical ASD, Inc. | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| 2013-07-10 | Smiths Medical ASD, Inc. | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| 2013-07-10 | Smiths Medical ASD, Inc. | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| 2013-07-10 | Smiths Medical ASD, Inc. | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
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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.