Recall Z-2950-2011 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Terumo Cardiovascular Corporation
CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intend
| Date | Aug 4, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| Reason | Reservoir blood bag used in cardiovascular procedures may leak. |
| Root cause | Nonconforming Material/Component |
| Action | Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form |
| Quantity | 253 reservoirs |
| Distribution | (USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.