# FDA recall Z-1779-2022

> **SunMed Holdings, LLC** · Class II · device recall initiated 2022-09-08.

## Product

Full Kit Pulset 3cc Syringe 23g x 1  Safety Tip 25u BH,  REF Number 3373-91

## Reason for recall

The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

## Distribution

Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.

## Key facts

- **Recall number:** Z-1779-2022
- **Recalling firm:** SunMed Holdings, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-09-08
- **Report date:** 2022-10-05
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2022

## Citation

> AI Analytics. FDA recall Z-1779-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1779-2022. Source: US FDA. Licensed CC0.

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