PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1579-2020.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1579-2020.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Bard Peripheral Vascular Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1579-2020.
Bard Peripheral Vascular Inc
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Bard Peripheral Vascular Inc Recall FAQ
Bard Peripheral Vascular Inc is the subject of a medical implants safety report: PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00.... The notice was published on October 1, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 296 units are potentially affected.