# FDA recall Z-2088-2023

> **DeRoyal Industries Inc** · Class II · device recall initiated 2023-05-30.

## Product

Custom medical procedure packs labeled as:    a)	STANDARD OB PACK ASCENSION WI, REF 89-10640  b)	ANGIO PACK, REF 89-10901  c)	BASIN, REF 89-1924  d)	CYSTO PACK, REF 89-7133  e)	TOTAL HIP PACK, REF 89-9134  f)	EMERGENCY C-SECTION PACK, REF 89-9478

## Reason for recall

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2088-2023
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-30
- **Report date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2088-2023

## Citation

> AI Analytics. FDA recall Z-2088-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2088-2023. Source: US FDA. Licensed CC0.

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