Draeger Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1452-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 25, 2014

Date Posted: April 16, 2014

Recall Number: Z-1452-2014

Event ID: 67808

Reason for Recall:

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

Status: Terminated

Product Quantity: 433

Code Information:

Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542.

Distribution Pattern:

USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.

Voluntary or Mandated:

Voluntary: Firm initiated