Recalls and Safety Alerts:
Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication
ASP has notified the FDA of a critical shortage of Sterrad Cyclesure 24 Biological Indicators due to a machine performance issue on its production line…
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall
Affected prongs may detach from the nasal tubing during use, especially when mucous and/or moisture are present…
Baxter ABACUS TPN Calculation Software: Class I Recall
Recall due to software failures when using ABACUS TPN calculation software…
Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall
A retaining ring could separate within the fan assembly, causing the fan to stop rotating…
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall
The pump may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used...
Ventlab Resuscitator Bags: Recall
Recall due to a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient…
Discussions with Healthcare Providers:
Clinical Electronic Thermometers: Small Sample Survey Summary
The purpose of this survey is to enhance FDA’s understanding of clinicians' perspectives on clinical electronic thermometers...
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