Recall Z-0499-2023— 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, SAFETY PINS, SMALL 1" Item No.515-001. 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, SAFETY PINS, SMALL 1" Item No.515-001
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.