FDA-Device2017-06-21Class II
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
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 untis distributed in U.S., 4,371 units distributed internationally
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2333-2017Don't want to check this manually?
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