# FDA recall Z-2642-2023

> **Wolf, Henke Sass, Gmbh** · Class II · device recall initiated 2023-07-27.

## Product

Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body.    Ref: 4100.000V0

## Reason for recall

Sterile barrier might be damaged compromising the sterility of the device.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-2642-2023
- **Recalling firm:** Wolf, Henke Sass, Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-27
- **Report date:** 2023-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tuttlingen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2642-2023

## Citation

> AI Analytics. FDA recall Z-2642-2023. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-2642-2023. Source: US FDA. Licensed CC0.

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