Recall Z-1465-2014 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
| Date | Apr 16, 2014 (initiated Mar 28, 2014) |
| Status | Terminated |
| Reason | Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits |
| Root cause | Labeling mix-ups |
| Action | Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product. |
| Quantity | 37 units |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.