FDA recall Z-0966-2019
Terumo Cardiovascular Systems Corporation · Class II · device
Product
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
Distribution
TX
Key facts
- Status
- Terminated
- Initiation date
- 2018-12-20
- Report date
- 2019-03-06
- Termination date
- 2019-08-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Elkton, MD, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2019