Device product
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
Z-2774-2016
Product summary
- Event
- Event 74898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,121 units in total
- Official record key
device-enforcement:Z-2774-2016
Official wording
Reason: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Code information: Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285
Distribution pattern: US Distribution to states of: NC, OH, FL, and MD.
Derived failure modes
-
Unknown
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.