Z-2465-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- May 19, 2020
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 kits
Product Description
Isolation Droplet Bundle Kit
Reason for Recall
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.
Distribution Pattern
Domestic distribution only to: MO and LA.
Code Information
Item: 830006013, Lot #: 78253M