Z-1452-2014Class II

Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and...

Name: Z-1452-2014 Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and...
Creator: Draeger Medical, Inc.
Published: 2014-03-25
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2014-03-25 / Terminated / root cause: labeling and UDI

FDA source

Draeger Medical, Inc. began a recall of 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... on 2014-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1452-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Posted: 2014-04-10
Terminated: 2014-10-08
Recalling firm: Draeger, Inc.
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.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.
Quantity in commerce: 433
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1452-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1452-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-10

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)