FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Isolation Droplet Bundle Kit
- Recall number
- Z-2465-2020
- Recalling firm
- ROi CPS LLC
- Product
- Isolation Droplet Bundle Kit
- Status
- Terminated
- Initiated
- 2020-05-19
- Posted
- not on file
- Terminated
- 2020-09-01
- 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.
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 24 kits
- Distribution
- Domestic distribution only to: MO and LA.
- Lot, serial or model codes
- Item: 830006013, Lot #: 78253M
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEA
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28