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Curaplex
BOUND TREE MEDICAL, LLC · Model TA-UEP · UDI-DI 00815277022873
MRZ
Prescription
10
510(k) clearances
543
Adverse events
8
Recalls
36
Facilities
Description
Thermal Angel Ultra Emergency Pack, incl 2 IV Fluid Warmers, 2 Ext Sets, Battery, Charger, Cable
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.