FDAFDA · Food and drugs·Recall number Z-0715-2020
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Published December 25, 2019 · Recall initiated: November 15, 2019
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
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- U.S. Nationwide, Canada
- Lot
- Lot Number: 16F19H0089
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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