Device product
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Z-1917-2026
Product summary
- Event
- Event 98618
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95
- Official record key
device-enforcement:Z-1917-2026
Official wording
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Code information: Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671
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