Recall Z-1452-2014— Draeger Medical, Inc.

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2014-03-25, terminated 2014-10-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.. Reason: Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Dr¿ger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. A.

Recalling firm

Draeger Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-03-25

Terminated

2014-10-08

Firm location

Telford, PA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.