Recall Z-0949-2022— Terumo Cardiovascular Systems Corp

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corp, initiated 2022-02-03, terminated 2024-02-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardiovascular Procedure Kit catalog # 76645 & 73806. Reason: Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping..

Recalling firm
Terumo Cardiovascular Systems Corp
Classification
Class II
Status
Terminated
Initiated
2022-02-03
Terminated
2024-02-20
Firm location
Ashland, MA, United States

Product description

Cardiovascular Procedure Kit catalog # 76645 & 73806

Reason for recall

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

Data sourced from openFDA. This site is unofficial and independent of the FDA.