Recalls and Safety Alerts:
Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall
Some devices contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures...
Some devices contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures...
RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall
Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and separate from the rest of the Rotablator Rotational Atheroctomy System and cause injuries...
Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and separate from the rest of the Rotablator Rotational Atheroctomy System and cause injuries...
G5 Ventilator by Hamilton: Class I Recall
The ventilator may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient...
The ventilator may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient...
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall
The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery...
The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery...
Current Newsletter: December 2015 (PDF - 367KB)
Articles available within the current newsletter:
- In Brief - Recalls and Safety Alerts
- Highlighted Reports
- Links to FDA/CDRH Databases and Other Information Sources
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