Recall Z-0586-2023— DeRoyal Industries Inc
Class II · Ongoing
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2022-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal CATARACT PACK, REF 89-7135.10. Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-03
- Firm location
- Powell, TN, United States
Product description
DeRoyal CATARACT PACK, REF 89-7135.10
Reason for recall
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.