Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7: recall status
Notice names this product. ARROW INTERNATIONAL’s Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7 is named in FDA Class II recall Z-1917-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Identifying details: Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671. Units affected: 95. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Agency product description and boundaries
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.
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If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.