Class I - Dangerous
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
💧
Infusion Pumps
🏥 Medical Devices • 4,262 recalls
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
Class I - Dangerous
Potential for leakage at the joint between the blood filters and tubing
Cocoon Convective Warming System, Product Code: CWS5000 (110V).
Care Essentials Pty.
Class I - Dangerous
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
Care Essentials Pty.
Class I - Dangerous
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
Class I - Dangerous
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
Radiometer Medical ApS
Class I - Dangerous
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.