Device product
Isolation Droplet Bundle Kit
Z-2465-2020
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 85736
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 kits
- Official record key
device-enforcement:Z-2465-2020
Official wording
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.
Code information: Item: 830006013, Lot #: 78253M
Distribution pattern: Domestic distribution only to: MO and LA.
Derived failure modes
-
Labeling or packaging
labeling error