CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Baxter Healthcare
Class I - Dangerous
IV sets may leak.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Product: STA Liatest D-Di; REF: 00515;
Diagnostica Stago
Class I - Dangerous
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
Baxter Healthcare
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
IV sets may leak.
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Baxter Healthcare
Class I - Dangerous
IV sets may leak.
Class I - Dangerous
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
Class I - Dangerous
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class I - Dangerous
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
Class I - Dangerous
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
Class I - Dangerous
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.