FDA Posts Study Confirming OD Risk From ENFit LDT Syringes
The US FDA has posted a study affirming a safety communication the agency issued in October that warned of overdose risk from certain low dose tip syringes.
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The US FDA issued a safety communication to patients and health care providers about the potential for overdose when using ENFit low dose tip syringes, and also told manufacturers to update labeling to account for the risk.
The US agency didn’t buy Stryker’s argument in its April petition that there is no data suggesting patient-transport devices have a history of false and misleading claims.