A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall – Risk of Continuous Infusion at a Rate Greater Than Expected. According to the Food & Drug Administration FDA’s MedWatch:
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, which can lead to serious adverse health consequences, including death.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall – Risk of Continuous Infusion at a Rate Greater Than Expected.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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