Dräger Faces FDA Class I Recall on Carina Ventilators Due to Contaminant Concerns

Dräger, Oxylog 2000, Oxylog 3000, Pediatric ventilators, FDA

Dräger, a German medical device manufacturer, is grappling with its fourth Class I recall by the FDA this year, this time involving the Carina sub-acute care ventilator. Although Dräger ceased production of these devices in 2019, they are still utilized in hospitals to provide breathing assistance to both pediatric and adult patients.

The recall stems from recent tests indicating that contaminants could potentially infiltrate the ventilator’s airpath at levels exceeding safety thresholds for children. Such exposure could result in toxic reactions or fatalities, although no related complaints have been reported thus far, according to the FDA.

More than 11,600 Carina ventilators are subject to the recall, distributed over a decade from 2009 to the present. In June, Dräger informed healthcare providers that routine tests of the polyether polyurethane (PE-PUR) foam, used for sound insulation in the devices, revealed the potential release of 1,3-Dichloropropan-2-ol—a potential carcinogen—into the airpath, particularly in prolonged pediatric use exceeding 30 days.

Dräger clarified that human studies haven’t shown a carcinogenic effect tied to elevated 1,3-Dichloropropan-2-ol levels and concluded that the risk of additional cancer cases was low in comparison to the general cancer risk.

Rather than recalling all Carina ventilators, the company issued a correction notice. Healthcare providers are instructed to discontinue the devices’ use for pediatric patients while still employing them for adults at higher minute volumes. Dräger intends to replace the noise-reducing PE-PUR foam with a newly designed blower cover, a process expected to be completed in the early fourth quarter of this year.

Once updated, the ventilators will be deemed safe for regular usage. Dräger expressed apologies for any inconvenience and emphasized the necessity of the measure to enhance patient safety.

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