Device product
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
Z-2333-2017
Product summary
- Event
- Event 77232
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,485 untis distributed in U.S., 4,371 units distributed internationally
- Official record key
device-enforcement:Z-2333-2017
Official wording
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information: Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A Device Listing D025768
Distribution pattern: Worldwide Distribution - US (nationwide) and Canada
Derived failure modes
-
Labeling or packaging
packaging may not be completely sealed, which may compromise
-
Sterility assurance
packaging may not be completely sealed, which may compromise sterility