Recall Z-0966-2019— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2018-12-20, terminated 2019-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222. Reason: Presence of natural rubber latex is not declared in the label.
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-20
- Terminated
- 2019-08-20
- Firm location
- Elkton, MD, United States
Product description
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Reason for recall
Presence of natural rubber latex is not declared in the label
Data sourced from openFDA. This site is unofficial and independent of the FDA.