Recall Z-1496-2025 ยท OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Draeger, Inc.
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 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
| Date | Apr 3, 2025 (initiated Mar 12, 2025) |
| Status | Open, Classified |
| Reason | The potential for cracks forming in the breathing circuit hose. |
| Root cause | Under Investigation by firm |
| Action | 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 Medica |
| Quantity | 780 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.