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

FDA Device Recall #Z-1452-2014 — Class II — March 25, 2014

Recall Summary

Recall Number Z-1452-2014
Classification Class II — Moderate risk
Date Initiated March 25, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draeger Medical, Inc.
Location Telford, PA
Product Type Devices
Quantity 433

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.

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

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.

Lot / 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.

Other Recalls from Draeger Medical, Inc.

Recall # Classification Product Date
Z-0668-2025 Class I Brand Name: Atlan Product Name: Atlan A300XL ... Oct 15, 2024
Z-0304-2025 Class I Brand Name: Atlan Product Name: Atlan A350 Mo... Oct 15, 2024
Z-0305-2025 Class I Brand Name: Atlan Product Name: Atlan A350XL ... Oct 15, 2024
Z-0667-2025 Class I Brand Name: Atlan Product Name: Atlan A300 ... Oct 15, 2024
Z-1512-2024 Class I Dr¿ger Perseus A500 Anesthesia Workstation Mar 20, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.