Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
This recall has been terminated (originally issued December 20, 2018).
- Recall Initiated
- December 20, 2018
- Terminated
- August 20, 2019
- Recall Number
- Z-0966-2019
- Quantity
- 12 packs
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of natural rubber latex is not declared in the label
Distribution
TX
Lot / Code Info
Lot Numbers: V A30
Root Cause
Component design/selection
Action Taken
Terumo issued Urgent Medical Device Recall dated 12/20/18 stating reason for recall, health risk and an appropriate course of action for the return of affected product to Terumo. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET.