Recall Z-1869-2009 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Maquet Cardiovascular
Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804,
| Date | Aug 31, 2009 (initiated May 19, 2009) |
| Status | Terminated |
| Reason | Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex. |
| Root cause | Process control |
| Action | Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009. |
| Quantity | 2,226 devices |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.