FDA-Device2017-06-21Class II

Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation

Arrow International Inc
Hazard

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Sold states
Worldwide Distribution - US (nationwide) and Canada
Affected count
27,485 units distributed in U.S., 4,371 units distributed internationally
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2017

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