Four FDA Class I Recalls This Week

In short

The US FDA has issued four Class I recalls in three days. Class I designation is reserved for problems that could have life affecting consequences, making them the FDA’s most serious.


FDA Class I recalls normally occur some time after the manufacturer identified a problem and undertook its own recall activity. So is the case with all of the four recalls notified by the agency this week. For full information regarding the recalls, click here to find FDA’s source page.

A quick rundown of the recalls notified this week then:

CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12. Recall initiated March 6 2013: CareFusion has received reports of a communication error on the Alaris PC unit (model 8015) with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

LifeScan, Inc., OneTouch Verio IQ Blood Glucose Meter. Recall initiated March 11, 2013: Failure to provide a warning at extremely high blood glucose levels.

GE Healthcare, Giraffe OmniBed and Giraffe Incubator. Recall initiated Jan 8 2013: The devices may randomly delete stored information and enter new information in its place (over-write) when the device turns “on” or recovers from a power failure. When this occurs, the heater or oxygen delivery option will turn “off” and the new set point will be “0”. In addition, alarms may not appropriately alert users that heater or oxygen delivery options are “off” or that the set points are less than intended. The alarm failure may go unnoticed.

Engineered Medical Systems, Inc., SealFlex Single Port Ribbed Mask (Infant). Recall initiated Sept 12, 2011: The mask inside the package has been identified as “Neonatal” in size and not “Infant” as the labeling indicates. The use of an improperly-sized mask may cause serious adverse health consequences, including death.

Source: FDA


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