FDA Device recall Z-1452-2014
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets
- FDA Device
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets by Draeger Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1452-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-25 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Draeger Medical |
| Distribution | US |
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
Identifiers
| code_info | Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, an…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1452-2014%22
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