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

BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for — recall Z-1577-2020

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-1577-2020
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)
00801741025860
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.