# FDA recall Z-1100-2023

> **Quest Medical, Inc.** · Class II · device recall initiated 2022-12-23.

## Product

Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

## Reason for recall

Delivery Sets may have tubing that could become detached that could result in patient infection.

## Distribution

US Nationwide distribution in the state of MA.

## Key facts

- **Recall number:** Z-1100-2023
- **Recalling firm:** Quest Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-23
- **Report date:** 2023-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allen, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2023

## Citation

> AI Analytics. FDA recall Z-1100-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1100-2023. Source: US FDA. Licensed CC0.

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