Recall Z-1132-2022— Stradis Healthcare
Class II · Ongoing
Class II FDA medical device recall by Stradis Healthcare, initiated 2022-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Surgical Suture Kit. Reason: There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity..
- Recalling firm
- Stradis Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-22
- Firm location
- Waukegan, IL, United States
Product description
Surgical Suture Kit
Reason for recall
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.