Device product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.
Z-2136-2016
Product summary
- Event
- Event 74362
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1, 170 units
- Official record key
device-enforcement:Z-2136-2016
Official wording
Reason: Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
Code information: Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084
Distribution pattern: US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
Derived failure modes
-
Unknown
Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.