FDAFDA · Food and drugs·Recall number Z-2328-2017
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
Published June 21, 2017 · Recall initiated: May 9, 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
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- Worldwide Distribution - US (nationwide) and Canada
- Lot
- Material number: Ask-04301-WBH Device Listing D040650
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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