ROi CPS LLC Isolation Droplet Bundle Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Isolation Droplet Bundle Kit
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Item: 830006013, Lot #: 78253M
Products Sold
Item: 830006013, Lot #: 78253M
ROi CPS LLC is recalling Isolation Droplet Bundle Kit due to 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 late. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 19, 2020 Roi CPS LLC notified its customers to review their inventory to determine if the custom procedure kit item and lot identified were on their inventory. If identified, please quarantine and notify Roi of the quantity on hand completing the reply form provided to them via email and to forward this notification to all potential user of the recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
LA, MO
Page updated: Jan 10, 2026