Recall Z-2465-2020— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2020-05-19, terminated 2020-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Isolation Droplet Bundle Kit. Reason: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-19
- Terminated
- 2020-09-01
- Firm location
- Republic, MO, United States
Product description
Isolation Droplet Bundle Kit
Reason for recall
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.