# FDA recall Z-0088-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-09-01.

## Product

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF  VC-PPH-67A.  Cardiovascular procedure convenience kit.

## Reason for recall

Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018

## Distribution

CA

## Key facts

- **Recall number:** Z-0088-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-09-01
- **Report date:** 2022-10-19
- **Termination date:** 2026-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2023

## Citation

> AI Analytics. FDA recall Z-0088-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0088-2023. Source: US FDA. Licensed CC0.

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