Isolation Droplet Bundle Kit recall: Labeling Error
Isolation Droplet Bundle Kit
Why was Isolation Droplet Bundle Kit recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item: 830006013, Lot #: 78253M
- Product
- Isolation Droplet Bundle Kit
- Recalling firm
- ROi CPS LLC
- Quantity
- 24 kits
- Distribution
- Domestic distribution only to: MO and LA.
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)