Recall Z-0950-2022— Resource Optimization & Innovation LLC
Class II · Terminated
Class II FDA medical device recall by Resource Optimization & Innovation LLC, initiated 2022-02-28, terminated 2022-05-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site. Reason: A kit component, the PDI Prevantics Swab, was recalled..
- Recalling firm
- Resource Optimization & Innovation LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-28
- Terminated
- 2022-05-24
- Firm location
- Saint Louis, MO, United States
Product description
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Reason for recall
A kit component, the PDI Prevantics Swab, was recalled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.