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
Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2333-2017
Product Description
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
Reason for Recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 27,485 untis distributed in U.S., 4,371 units distributed internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Arrow International Inc. Units affected: 27,485 untis distributed in U.S., 4,371 units distributed internationally.
Why was this product recalled? ▼
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2333-2017.
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