Recall Z-0318-2021 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
OriGen Biomedical, Inc.
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
| Date | Jun 24, 2019 |
| Status | Terminated |
| Reason | The firm has become aware that they have distributed product that was expired. |
| Root cause | Nonconforming Material/Component |
| Action | On 6/24/2019, a email was sent to the affected customer informing them that the product was expired and requesting that it be returned. |
| Quantity | 6 units |
| Distribution | US: TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile International Biophysics Corporation, Dec 15, 2017 |