Home › Sol-Millennium Medical, Inc. › SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle
SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle
Sol-Millennium Medical, Inc. · Model 100079IM · UDI-DI 00818392014792
MEG
Prescription
10
510(k) clearances
2,941
Adverse events
17
Recalls
138
Facilities
Description
Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries.
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.