Cardinal Health GEL PACK REUSABLE recall: Labeling Error
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Why was Cardinal Health GEL PACK REUSABLE recalled?
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All lots
- Product
- Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 1915308 units
- Distribution
- nationwide and Canada
- Recall date
- November 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)