Device product
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Z-2332-2017
Product summary
- Event
- Event 77232
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,485 units distributed in U.S., 4,371 units distributed internationally
- Official record key
device-enforcement:Z-2332-2017
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: ASK-45703-AH, CDC-42703-1A, CDC-42703-1A, CDC-42854-1A, CDC-45703-1A, CDC-45703-A1A, CDC-45703-B1A, CDC-45854-1A, CDC-47702-1A Device Listing D213817
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