March 2017 MedSun Newsletter
Recalls and Safety Alerts:
Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall Affected devices are fracturing at a higher rate than is stated in the labeling which may result in revision surgeries…
Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall Recall due to a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the health care provider to clear the alarm to restart the infusion…
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall The sheath body may separate from the sheath hub while removing the device from the patient's leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure…
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