FDA-Device2023-10-25Class II
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Access Vascular, Inc
Hazard
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Sold states
US Nationwide distribution in the states of IL, TX.
Affected count
58 total
Manufactured in
749 Middlesex Tpke, N/A, Billerica, MA, United States
Products
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief