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Sapphire External Battery Pack

EITAN MEDICAL LTD · Model 15079-111-0001 · UDI-DI 17290109153992

MRZ

510(k) clearances

537

Adverse events

Recalls

Facilities

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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Data 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.