FDAFDA · Food and drugs·Recall number Z-0182-2018
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
Published December 6, 2017 · Recall initiated: June 1, 2017
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
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
- Lot
- Lot/Batch Number: 23F16L0021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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