Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Va...
FDA Device Recall #Z-1692-2023 - Class II, April 17, 2023
Recall Summary
| Recall Number | Z-1692-2023 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 17, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DeRoyal Industries Inc |
| Location | Powell, TN |
| Product Type | Devices |
| Quantity | 23 cases (52 packs) |
Product Description
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
Reason for Recall
The custom procedure packs contain light handle covers that have been recalled by another firm.
Distribution Pattern
US Nationwide distribution in the state of VA.
Lot / Code Information
(1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.
Other Recalls from DeRoyal Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2305-2026 | Class II | DeRoyal Industries Inc. Ref 46-406, Covaderm ... | May 18, 2026 |
| Z-1291-2025 | Class II | DeRoyal REF 71-C5100NS Tubing, Suction, Connect... | Jan 31, 2025 |
| Z-1174-2025 | Class II | DeRoyal AMG Suction Connector Tubing REF: 71-2... | Jan 15, 2025 |
| Z-0308-2025 | Class II | DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-934... | Oct 3, 2024 |
| Z-0307-2025 | Class II | DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-93... | Oct 3, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.