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Recall Observatory FDA recall evidence

Device product

Isolation Droplet Bundle Kit

Z-2465-2020

May 19, 2020

Class II

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

    reason.labeling_packaging · v1.0.0

    labeling error