Z-0115-2024Class II

HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

Name: Z-0115-2024 HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Creator: Access Vascular, Inc
Published: 2023-08-31
License: https://open.fda.gov/license/

Access Vascular, Inc / initiated 2023-08-31 / Open, Classified / root cause: labeling and UDI

FDA source

Access Vascular, Inc began a recall of HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 on 2023-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0115-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-31
Posted: 2023-10-13
Recalling firm: Access Vascular, Inc
Product: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 58 total
Distribution: US Nationwide distribution in the states of IL, TX.
Product codes and lots: UDI-DI: 00850030354068; Lot Number: 11469666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-13
Z-0115-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-13

Product code LJS

K213550Class IIHydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc. / cleared 2022-05-04

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)