Reported Oct 25, 2023 · Ongoing
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Access Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Access Vascular, Inc · 749 Middlesex Tpke · Billerica, MA · 01821-3906
Is this the product you have?
HydroPICC 5Fr Dual Lumen Maximal Barrier KitProduct Model Number 80002004
- Lot codes and dates
- UDI-DI00850030354068
- Lot Number11469666
- Amount recalled
- 58 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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