Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
- Company
- Draeger, Inc.
- Recall Initiated
- March 12, 2025
- Posted
- April 3, 2025
- Recall Number
- Z-1498-2025
- Quantity
- 9250 units
- Firm Location
- Telford, PA
Reason for Recall
The potential for cracks forming in the breathing circuit hose.
Distribution
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom
Lot / Code Info
Model/Catalog Number: MP02752; UDI Number 04048675389729; All lot numbers.
Root Cause
Under Investigation by firm
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.