FDA recall Z-0286-2024
Cordis US Corp · Class I · device
Product
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Reason for recall
Non-sterile product labeled as sterile was distributed.
Distribution
US Distribution to: OK
Key facts
- Status
- Ongoing
- Initiation date
- 2023-09-26
- Report date
- 2023-11-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Miami Lakes, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2024