Device product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied.
Z-1914-2026
Product summary
- Event
- Event 98618
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 395
- Official record key
device-enforcement:Z-1914-2026
Official wording
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Code information: Product Code: ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 Batch Number: 33F25L0140 Product Code: ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 Batch Number: 33F25L0143 Product Code: ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 Batch Number: 33F25L0144 Product Code: ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 Batch Number: 33F25L0145
Distribution pattern: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Derived failure modes
-
Unknown
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured