Dive Brief:
- Draeger asked hospitals to stop using several mechanical filters due to misleading carbon dioxide readings, according to a recall notice posted by the Food and Drug Administration on Tuesday.
- The SafeStar and TwinStar filters are used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination. Capnography readings are used to measure the amount of carbon dioxide exhaled while under anesthesia.
- The misleading carbon dioxide readings could cause healthcare providers to administer unnecessary or harmful treatments, according to the recall notice. The FDA said in the notice that serious injuries were reported, though the number of injuries was not listed. No deaths were reported.
Dive Insight:
Draeger began a recall of the SafeStar and TwinStar filters in June, according to an FDA enforcement report. The company sent an updated notice to customers on July 22, instructing them not to use the affected filters and to remove them from their stock. Draeger is directing hospitals to contact a representative to return and replace the products.
The filters are used in hospitals during surgery or in intensive care units. In total, the recall applies to four models of filters, encompassing nearly 12 million devices, according to the FDA’s enforcement report. The agency classified the recall in its highest risk category in July.
The FDA said serious injuries were reported due to the slow increase of the carbon dioxide curve when using the sampling port of the filter. The agency did not specify how many injury reports it had received. Use of the recalled filters can lead to airway injury, delayed or incorrect treatment, brain injury and death, the FDA said.
Draeger did not return MedTech Dive’s request for comment by publication.
