Recall Z-0071-2013 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to a
| Date | Oct 16, 2012 (initiated Oct 2, 2009) |
| Status | Terminated |
| Reason | Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch and two inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a |
| Root cause | Labeling design |
| Action | The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576. |
| Quantity | 33 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.