Device product
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit 6)AGB+Multi-Lumen Central Venous Catheterization Kit 7) AGB+Pressure Injectable Multi-Lumen CVC Kit The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days
Z-2330-2017
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-2330-2017
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-12703-PLV1, ASK-15703-PLV, ASK-15703-PRH, ASK-42703-PRJ, ASK-45703-PRH, ASK-45703-PRWJ1, AK-42703-P1A, AK-45703-P1A, CA-42703-P1A, CA-45703-P1A, CDA-42703-P1A, CDA-42802-P1A, CDA-45703-P1A, Device Listing D040746
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