Recall Z-1179-2021 ยท OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Draeger Medical, Inc.
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
| Date | Jan 29, 2021 |
| Status | Terminated |
| Reason | Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient. |
| Root cause | Process control |
| Action | Draeger Inc. (US) issued Urgent Medical Device Recall Letter via Certified Mail on January 29, 2021. The letter states reason for recall, health risk and action to take: Please check the quality of the adhesive joint before use by holding the Y-piece with one hand and then pulling (not twisting) each of the two hoses one after another so that the hose just starts to stretch visibly. Hoses that you have tested in this manner may be used if they pass the leakage test before use. Only use the hoses with devices that we have declared compatible in the Instructions for Use or accessories list of t |
| Quantity | 150 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.