Z-2550-2018 Class II Terminated
FDA device recall Z-2550-2018 was initiated by Terumo Cardiovascular Systems Corp on May 12, 2017 and is designated Class II. Reason for recall: Kit was labeled with the incorrect Expiration Date of April 30, 2019. The recall status is terminated (terminated October 26, 2018). Affected quantity: 30 cases/2 units (Total 60 units).
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- May 12, 2017
- Termination Date
- October 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 cases/2 units (Total 60 units)
Product 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 for Recall
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Distribution Pattern
US state of FL
Code Information
Lot Number: VE17