Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 F...
Reason for Recall / Hazard
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Morrisville |
| State | NC |
| Event id | 98618 |
| Address 1 | 3015 Carrington Mill Blvd |
| Address 2 | N/A |
| Code info | Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671 |
| Postal code | 27560-5437 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 95 |
| Reason for recall | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmARROW INTERNATIONAL, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.