Z-0486-2023 Class II Ongoing
FDA device recall Z-0486-2023 was initiated by Stradis Medical, LLC Dba Stradis Healthcare on Nov 2, 2022 and is designated Class II. Reason for recall: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of… The recall status is ongoing. Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Reason for Recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Distribution Pattern
US nationwide distribution, and Canada.
Code Information
UDI/DI (case) M75240510TWS1, UDI/DI (kit)M75240510TWS0, Serial/Lot Numbers: 22236490637
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0486-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026