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DANA 3cc Syringe
SOOIL DEVELOPMENT CO.,LTD · Model DANA 3cc Syringe · UDI-DI 08809220580765
MRZ
Prescription
1
510(k) clearances
537
Adverse events
8
Recalls
36
Facilities
Description
DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-19 | Smiths Medical ASD Inc. | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a moldi |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2018-11-08 | ICU Medical Inc | There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets. |
| 2009-11-02 | Animas Corporation | Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. |
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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.