FDAFDA · Food and drugs·Recall number Z-2136-2016
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.
Published July 13, 2016 · Recall initiated: June 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.