Recall Z-0839-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
| Date | Feb 20, 2013 (initiated Dec 26, 2012) |
| Status | Terminated |
| Reason | ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. |
| Root cause | Nonconforming Material/Component |
| Action | Maquet sent Urgent Device Recall Letters/Recall Acknowledgement Forms to their customers on 12/26/2012. |
| Quantity | 41 units - US Distirbution; 216 units - OUS Distribution |
| Distribution | Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002857 | ELS CANNULA (KIT), MODEL M1210-88,M1510-88 Jostra AG, Oct 5, 2000 |