Recall Z-0257-2018 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478
| Date | Jun 27, 2017 |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. |
| Root cause | Process change control |
| Action | The firm sent a safety alert to its consignees on 07/27/2017 by mail. The notice requested that the consignee test the product prior to using. If the product did not operate, the consignee was asked to return it. Beginning on 12/11/2017 the firm conducted a removal by mail of any remaining product. The customer instructions are as follows: CUSTOMER INSTRUCTIONS Review this Medical Device Recall Notice. Assure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product that is subject to this action. Confirm receipt of this notification by comp |
| Quantity | 214146 units |
| Distribution | Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820297 | WM. HARVEY OVERPRESSURE SAFETY VALVE C.R. Bard, Inc., Mar 12, 1982 |