FDA Provides Update on Dräger’s Recall of Its Breathing System Filter

The FDA has issued an update on Dräger’s May 16 recall of its SafeStar 55 breathing system filter with lot number LT2103, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is that an obstructed SafeStar 55 breathing system filter was used on a patient during anesthesia who “reportedly became hypoxic and had to be reanimated,” according to the company.

The manufacturing problem was linked to “a human error” while equipment was being serviced. An employee mistakenly placed a filter that had failed a resistance test in the wrong box, the company explained, adding that most likely only one filter was affected, but it is recalling the entire lot to be safe.