FDA Medical Device Recalls (openFDA)
Access Vascular, Inc: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
- Recall number
- Z-0115-2024
- Recalling firm
- Access Vascular, Inc
- Product
- HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
- Status
- Open, Classified
- Initiated
- 2023-08-31
- Posted
- 2023-10-13
- Terminated
- not on file
- Reason
- 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
- 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
- 58 total
- Distribution
- US Nationwide distribution in the states of IL, TX.
- Lot, serial or model codes
- UDI-DI: 00850030354068; Lot Number: 11469666
- 510(k) numbers
- ["K213550"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 3021570645
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28