ARROW INTERNATIONAL, LLC: 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
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ARROW INTERNATIONAL, LLC
- 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.
- Reason / hazard
- Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
- Recall initiated
- 2026-03-11
- Code info
- Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671
- Product quantity
- 95
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Morrisville
- State
- NC
- Country
- United States
- Event id
- 98618
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