Z-0199-2023Class II

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Name: Z-0199-2023 Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Creator: Access Vascular, Inc.
Published: 2021-02-24
License: https://open.fda.gov/license/

Access Vascular, Inc / initiated 2021-02-24 / Terminated / root cause: manufacturing process

FDA source

Access Vascular, Inc. began a recall of Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter on 2021-02-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0199-2023
Classification: Class II
Status: Terminated
Initiated: 2021-02-24
Posted: 2022-11-08
Terminated: 2024-05-30
Recalling firm: Access Vascular, Inc
Product: Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 79 kits
Distribution: Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0199-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-16	2022-11-07

Product code LJS

K193015Class IIHydroPICC (PICC-142)Access Vascular, Inc. / cleared 2020-02-20

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)