HydroPICC recallZ-0199-2023 · Access Vascular, Inc. · initiated Feb 24, 2021
Terminated
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
Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
FDA root cause category: Process design
What the company is doing
Beginning February 24, 2021, the firm notified its affected consignees via Email. Customers were informed that if product had already been used, then no action was required, because all components were still within their expiration date at the time, and no patient safety risk was identified. If product had not been used, customers were asked to refrain from using product until a replacement Scalpel and Statlock were provided.
Recall details
- Recall number
- Z-0199-2023
- Status
- Terminated
- Initiated by the company
- Feb 24, 2021
- Posted by the FDA
- Nov 8, 2022
- Recalling firm
- Access Vascular, Inc.
- Quantity
- 79 kits
- Product code
- LJS
- FDA submissions
- K193015
- Distribution
- Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
Product description
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Code information (models, lots, serial numbers)
UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HydroPICC PICC-142Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall4 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under K193015 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HydroPICC Maximal Barrier Kit 80001004Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall7 reports
- HydroPICC Basic Kit (80cm GW) 80001002Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall1 report
- HydroPICC Basic Kit (130cm GW) 80001001Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall0 reports
- HydroPICC Maximal Barrier Kit 80H01104Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days9 reports
- HydroPICC Basic Kit (70cm GW) 80H01102Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 reports
- HydroPICC Catheter PICC-142CMAccess Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 reports
- HydroPICC PICC-142SAccess Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 reports
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.
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