ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0147-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Complete FDA and NHTSA recall records dated in October 2019.
These records include useful source details for the selected month.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Due to low Quality Control recovery and invalid Calibration.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Due to low Quality Control recovery and invalid Calibration.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.