Z-0598-2023 Class II Ongoing
FDA device recall Z-0598-2023 was initiated by DeRoyal Industries Inc on Nov 3, 2022 and is designated Class II. Reason for recall: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. The recall status is ongoing. Affected quantity: 30 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 kits
Product Description
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
Reason for Recall
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Distribution Pattern
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Code Information
Lot Numbers: Lot 57746997 exp 12/1/2026
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0598-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026