Recall Z-2550-2018 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corp
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
| Date | May 12, 2017 |
| Status | Terminated |
| Reason | Kit was labeled with the incorrect Expiration Date of April 30, 2019. |
| Root cause | Incorrect or no expiration date |
| Action | On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined. |
| Quantity | 30 cases/2 units (Total 60 units) |
| Distribution | US state of FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.