Recall Z-0501-2023— Stradis Medical, LLC dba Stradis Healthcare
Class II · Ongoing
Class II FDA medical device recall by Stradis Medical, LLC dba Stradis Healthcare, initiated 2022-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray. Reason: 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..
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-02
- Firm location
- Peachtree Corners, GA, United States
Product description
STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.