# FDA recall Z-0199-2023

> **Access Vascular, Inc.** · Class II · device recall initiated 2021-02-24.

## Product

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

## 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.

## Distribution

Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

## Key facts

- **Recall number:** Z-0199-2023
- **Recalling firm:** Access Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-24
- **Report date:** 2022-11-16
- **Termination date:** 2024-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2023

## Citation

> AI Analytics. FDA recall Z-0199-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0199-2023. Source: US FDA. Licensed CC0.

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