Z-0541-2023 Class II Ongoing
FDA device recall Z-0541-2023 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: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
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) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 22237491038
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0541-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026