Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HydroPICC 5Fr Dual Lumen Recalled by Access Vascular, Inc Due to Specific lots of the Dual Lumen HydroPICC Kits...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Access Vascular, Inc directly.
Affected Products
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Quantity: 58 total
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Access Vascular, Inc
Access Vascular, Inc has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report