# FDA recall Z-1941-2021

> **Cardinal Health Inc.** · Class II · device recall initiated 2021-03-16.

## Product

OPTICHAMBER DIAMOND SPACER WITH LARGE MASK  Item Number: 4742326

## Reason for recall

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

## Distribution

US Nationwide distribution in the states of FL, GA, SC.

## Key facts

- **Recall number:** Z-1941-2021
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-16
- **Report date:** 2021-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2021

## Citation

> AI Analytics. FDA recall Z-1941-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1941-2021. Source: US FDA. Licensed CC0.

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