# FDA recall Z-1691-2023

> **DeRoyal Industries Inc** · Class II · device recall initiated 2023-04-17.

## Product

Sterile custom surgical procedure packs:    (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital;  (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital;  (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital;  (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center;  (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center;  (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center;  (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center;  (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp;  (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp;  (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital;  (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital;  (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital;  (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial  Hospital;  (14) 89-10555.02, 

## Reason for recall

The custom procedure packs contain light handle covers that have been recalled by another firm.

## Distribution

US Nationwide distribution in the state of VA.

## Key facts

- **Recall number:** Z-1691-2023
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-17
- **Report date:** 2023-06-14

- **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-1691-2023

## Citation

> AI Analytics. FDA recall Z-1691-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1691-2023. Source: US FDA. Licensed CC0.

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