Recalls / —
—#170572
Product
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
- FDA product code
- OEZ — Cardiovascular Procedure Kit
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Lot Numbers: V A30
Why it was recalled
Presence of natural rubber latex is not declared in the label
Root cause (FDA determination)
Component design/selection
Action the firm took
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.
Recalling firm
- Firm
- Terumo Cardiovascular Systems Corporation
- Address
- 125 Blue Ball Rd, Elkton, Maryland 21921-5315
Distribution
- Distribution pattern
- TX
Timeline
- Recall initiated
- 2018-12-20
- Terminated
- 2019-08-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170572. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.