Draeger Recalls Reusable Latex Breathing Bags Due to Allergic Reaction Incident
Draeger Medical is recalling reusable latex breathing bags and test lungs after a user reported an acute allergic reaction. The product is distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where an acute allergic reaction occurred, but the source explicitly states the user did not suffer permanent injury, fitting the 'High' criteria for risk-of-harm products where serious injury has not been reported.
Plain-English summary
Draeger Medical, Inc. is recalling reusable latex breathing bags, test lungs, and reusable anaesthesia sets. The recall was initiated after the company became aware of an incident where a user suffered an acute allergic reaction after using a Dräger latex test lung. The user did not suffer permanent injury.
The affected products include reusable latex breathing bags with part numbers 2165686, 2165953, and 2165694, as well as test lung part number 8403201 and reusable anaesthesia sets with part numbers M33681 and M27542. These items are components of anesthesia sets intended to administer medical gases to patients during ventilation or used for device system checkouts.
A total of 433 units were distributed nationwide in the United States, including states such as Michigan, South Carolina, Colorado, Ohio, and New York. The breathing bags are labeled 'NR'. Consumers and healthcare facilities should stop using these products and contact Draeger Medical for further instructions.
The recalled product
- 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 me
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- Affected units
- 433
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Related recalls
Same manufacturer · Draeger Medical, Inc.
See all →- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- SevereDräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
FDA (Devices) · 2024-04-24
Same hazard · latex allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15