FDAFDA · Food and drugs·Recall number Z-2329-2017
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
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-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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