HydroPICC Dual Lumen recallZ-0114-2024 · Access Vascular, Inc · initiated Aug 31, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Access Vascular, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Error in labeling
What the company is doing
An Urgent Medical Device Correction notification letter dated 8/25/23 was sent to customers. Our records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety. - Product that has already been used: No action required. All catheters to date have been used with adult patients. - Product that has not been used: The kit does not have the current IFU. Please refer to the Rev C. IFU provided with this letter. Also, the Patient Information Card, part number LS-067, includes a barcode link to the current revision of the IFU on AVIs website. The following page identifies the shipments you have received with these impacted lots. Please forward this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your inventory and determine the appropriate correction with your input, in a timely manner. If you have any questions about this communication, please contact us at 781-538-6594.
Recall details
- Recall number
- Z-0114-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 31, 2023
- Posted by the FDA
- Oct 13, 2023
- Recalling firm
- Access Vascular, Inc
- Quantity
- 58 total
- Product code
- LJS
- FDA submissions
- K213550
- Distribution
- US Nationwide distribution in the states of IL, TX.
Product description
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Code information (models, lots, serial numbers)
UDI-DI: 00850030354044; Lot Number: 11423187
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HydroPICC Dual Lumen 80002002Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall1 report
Product lines
Other devices under the same FDA submission
2 devices cleared under K213550 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HydroPICC Dual Lumen 80002004Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall1 report
- HydroPICC Dual Lumen 80H02104Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93043).
- Z-0115-2024 · Open, ClassifiedHydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page