FDA Recall
Terminated
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.
Recall: Z-2550-2018
·
Initiated May 12, 2017
Recall
- Recall Number
- Z-2550-2018
- Event Number
- 80283
- Firm
- Terumo Cardiovascular Systems Corp
- FEI Number
- 1000149028
- Product Code
- OEZ
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- May 12, 2017
- Terminated
- October 26, 2018
- Address
- 28 Howe St, Ashland, MA, 01721-1305
Description
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.
Reason
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
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.
Distribution
US state of FL
Quantity
30 cases/2 units (Total 60 units)