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CAINA
Jiangsu Caina Medical Co.,Ltd · Model 1ml 25G*1 · UDI-DI 06971564465618
10
510(k) clearances
2,941
Adverse events
17
Recalls
138
Facilities
Description
The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
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.