Recalls and Safety Alerts:
I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall
Bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position...
Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall
Incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions...
CareFusion Alaris Pump Module Model 8100: Class I Recall
Recall due to reports of motor stalls during infusion with model 8100...
CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall
Pump module door keypad overlay may become loose, peel away, or separate from the door assembly...
Synthes Hemostatic Bone Putty: Class I Recall
Potential for this product to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery...
Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding Pads
Recall due to the potential degradation of foil within the DGPHP grounding pad...
Hospira Propofol Injectable Emulsion: Recall
Recall due to visible particles embedded in the glass to the user level...
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication
Physicians should continue to closely monitor patients who have a Riata or Riata ST lead and notify patients if they have a recalled lead...
Covidien Shiley Adult Tracheostomy Tubes: Class I Recall
Recall due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae...
Stryker Wingspan Stent System: Safety Communication
The indications for use and labeling for the Wingspan stent have changed to limit the use to a narrow, select group of patients and conditions...
Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall
System errors may cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running...
Respironics, Inc., Trilogy 100, 200, and 202 Ventilators: Class I Recall
Defective power supply components may cause unexpected cessation of function, thereby stopping ventilation of the patient...
B. Braun Infusomat Space Infusion System: Class I Recall
Potential for breakage of the anti free flow clip catch located inside the infusion pump door...
CareFusion Alaris PC Unit, Model 8015: Class I Recall
If an error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy...
Benzalkonium Chloride Antiseptic Wipes by Dukal - Recall
Use of contaminated wipes could lead to infections, some of which pose health risks in immune-suppressed patients...
Webinars and Educational Materials:
Webcast: MedSun Reporting by Biomedical and Clinical Engineers: Sites' Safety Stories and Successes
| 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 |  |
