FDA (Devices) recall action 76138
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
The agency’s own wording, quoted from the enforcement report.
Atrium Medical Corporation is recalling 8 Fr Straight Thoracic Catheters because the label depicts six eyelets instead of the correct two.
Atrium Medical Corporation is recalling 1,394 cases of 10 Fr Straight Thoracic Catheters because the label icon incorrectly depicts six eyelets instead of two.