Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Ve

FDA device recall Z-1496-2025 · posted 2025-04-03 · Open, Classified

Recall details

Recalling firm

Draeger, Inc.

Reason for recall

The potential for cracks forming in the breathing circuit hose.

Action taken

On March 12, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken When using these breathing circuits: 1. Use holders with a larger contact surface (see Figure 2 above). 2. Perform leak testing after stretching the flexible hose to the required length for the application. Please observe the products Instructions for Use (IFU) According to our records, you have received at least one of the listed breathing circuits. Please inform all potential users in your facility. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification. Please also complete the enclosed Medical Device Recall Return Response Acknowledgment and Receipt Form to confirm to us that you have received this information. Adverse events or quality problems experienced with the use of this product may be reported to FDA s MedWatch Adverse Event Reporting program either online or by phone at 1-800-FDA-1088. We apologize for any inconveniences resulting from this action. If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com. The US Food and Drug Administration has been advised of this action. ****Update 07/08/2025****On June 25, 2025 URGENT MEDICAL DEVICE RECALL - UPDATE letters were sent to consignees to clarify and provide complete UDI information for the device to include both primary and secondary UDI numbers as errors were identified in the initial letter.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OFP

Quantity affected

780 units

Distribution

Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Ja

Date initiated

2025-03-12

Date posted

2025-04-03

Location

Telford, PA