Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1579-2020 — PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be us

U.S. FDA — Device Enforcement · United States · 2019-10-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1579-2020
Date of alert
2019-10-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bard Peripheral Vascular Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00801741129438
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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