Recall Z-2178-2018 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components a
| Date | Jul 27, 2017 |
| Status | Terminated |
| Reason | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. |
| Root cause | Nonconforming Material/Component |
| Action | On 7/27/17, an Urgent Safety Alert was issued to customers of the Cardiovascular Procedure Kit with LN130B Over-pressure Safety Valves. The safety alert instructed customers to perform the following: Please examine your inventory immediately to determine if you have unused kits of the batch numbers listed. If so, please follow the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. It is possible that custom tubing kits with the affected valves may have already been used without issue. Customers were instructed to test the valve prior to use. T |
| Quantity | 10 |
| Distribution | The products were distributed to the following US states: IA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080592 | HLM TUBING SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG, Sep 11, 2008 |