Lower riskMedical device recall · FDA · Published August 31, 2023
Access Vascular HydroPICC Kit: Incorrect Instructions Risk Adult Use Only
Access Vascular recalls HydroPICC 5Fr Dual Lumen kits with incorrect instructions that omit adult use warnings. This could risk harm if used in inadequately sized vessels. No injuries reported.
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.
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Contact the company
📍Recalling firmAccess Vascular, Inc749 Middlesex Tpke · Billerica, MA 01821-3906
✎ GovInfoNow plain-language explainer
Access Vascular is recalling HydroPICC 5Fr Dual Lumen kits with a specific model number because they came with incorrect instructions that don't warn the device is for adult use only. Using these kits in inadequately sized vessels could cause health risks, though no injuries have been reported. Read more at govinfonow.com/recall/57409-access-vascular-hydropicc-kit-incorrect-instructions-risk-adult-use-only.
“Access Vascular HydroPICC Kit: Incorrect Instructions Risk Adult Use Only.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57409-access-vascular-hydropicc-kit-incorrect-instructions-risk-adult-use-only. Based on FDA recall #Z-0114-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2024%22&limit=1).
The FDA announced on August 31, 2023, that Access Vascular, Inc. is recalling HydroPICC 5Fr Dual Lumen kits due to incorrect Instructions For Use lacking necessary warnings. The agency issued recall number Z-0114-2024 for the Class II device.
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use which do not include warnings that the catheter is for adult use only and there is a potential risk to health should it be used in an inadequately sized vessel. There have been no reported adverse events to date.
Context
GovInfoNow's records show Access Vascular, Inc has 5 other recalls on record since February 24, 2021. Other recent recalls of similar products include Arrow MAC Two-Lumen Central Venous Access Kit Recall: Incorrect Adhesive Manufacturing (March 11, 2026), Arrow PI Midline 2L Catheter Recall: Risk of Serious Injuries from Contaminated Medication (April 21, 2026), and Medline Pelvic Lap Pack Kits: Catheter Issues Recalled (May 4, 2026).
How to tell if you have this one
Check for the model number 80002002 on the HydroPICC kit. The lot number 11423187 is associated with this specific recall.
Brand
Access Vascular
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of IL, TX.
Recall number
Product, codes & lots
Z-0114-2024
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002; UDI-DI: 00850030354044; Lot Number: 11423187
Z-0115-2024
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004; UDI-DI: 00850030354068; Lot Number: 11469666
Based on the official FDA remedy
What to do — step by step
Check Instructions
Verify the kit includes the correct Instructions For Use that state the HydroPICC Dual Lumen Catheter is for adult use only.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IL, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Texas.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0114-2024 (August 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0114-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.