Recall Z-2550-2018— Terumo Cardiovascular Systems Corp
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corp, initiated 2017-05-12, terminated 2018-10-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-12
- Terminated
- 2018-10-26
- Firm location
- Ashland, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.