FDA Device recall Z-2465-2020
Isolation Droplet Bundle Kit
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Isolation Droplet Bundle Kit by Roi Cps, citing 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 ki….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2465-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-19 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roi Cps |
| Distribution | LA, MO |
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.
Identifiers
| code_info | Item: 830006013, Lot #: 78253M |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2465-2020%22
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