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.
This recall has been terminated (originally issued April 10, 2014).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- March 25, 2014
- Posted
- April 10, 2014
- Terminated
- October 8, 2014
- Recall Number
- Z-1452-2014
- Quantity
- 433
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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 Drger 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
Distribution
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.
Lot / Code Info
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.
Root Cause
Labeling design
Action Taken
A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.