FDA Enforcement
Class I
Ongoing
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Recall: Z-0286-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0286-2024
- Event ID
- 93174
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cordis US Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- November 15, 2023
- Initiation Date
- September 26, 2023
- Classification Date
- November 9, 2023
- Address
- 14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802, United States
Description
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Reason
Non-sterile product labeled as sterile was distributed.
Code Info
UDI/DI 10705032025935, Lot Number 18223410
Distribution
US Distribution to: OK
Quantity
30 devices