Recall Z-0866-2022— Stradis Medical, LLC dba Stradis Healthcare
Class II · Ongoing
Class II FDA medical device recall by Stradis Medical, LLC dba Stradis Healthcare, initiated 2022-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Coryell Memorial Hosp Total, Joint Pack - Surgical Kit. Reason: The outer bag may be perforated or torn, 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
- 2022-02-25
- Firm location
- Peachtree Corners, GA, United States
Product description
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Reason for recall
The outer bag may be perforated or torn, 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.