Device product
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Z-0286-2024
Product summary
- Firm
- Cordis US Corp
- Event
- Event 93174
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 30 devices
- Official record key
device-enforcement:Z-0286-2024
Official wording
Reason: Non-sterile product labeled as sterile was distributed.
Code information: UDI/DI 10705032025935, Lot Number 18223410
Distribution pattern: US Distribution to: OK
Derived failure modes
-
Sterility assurance
Non-sterile product labeled as sterile