Class I - Dangerous
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
Complaints of leakage of insufflation gas through the device.
Complaints of leakage of insufflation gas through the device.
Class I - Dangerous
Complaints of leakage of insufflation gas through the device.
Class I - Dangerous
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
Complaints of leakage of insufflation gas through the device.
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
3M Company - Health Care Business
Class I - Dangerous
Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
AMS Diagnostics
Class I - Dangerous
Marketing the devices outside 510(k) requirements
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Class I - Dangerous
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
AMS Diagnostics
Class I - Dangerous
Marketing the devices outside 510(k) requirements