Recalls and Safety Alerts:
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication
The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects...
Avea Ventilator by CareFusion: Recall
Certain AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false extended high peak or circuit occlusion audio and visual alarms, opens the safety valve and stops ventilating...
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication
Affected devices may have security vulnerabilities, including software codes, which, if exploited, could allow an unauthorized user to interfere with the pump’s functioning...
Tiger Paw System II by Maquet Medical Systems: Class I Recall
Incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall during use of the device...
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
