Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
This recall is currently active, issued November 7, 2022. It was issued by Cardinal Health 200, Llc.
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- September 28, 2022
- Posted
- November 7, 2022
- Recall Number
- Z-0189-2023
- Quantity
- 499997 units
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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 .
Distribution
nationwide and Canada
Lot / Code Info
All lots
Root Cause
Pending
Action Taken
Cardinal Health sent an URGENT:MEDICAL DEVICE PRODUCT CORRECTION on 10/03/2022 by overnight mail. The notice explained the issue and requested the following: "Actions Required: 1. COMMUNICATE with all personnel that utilize these gel packs regarding appropriate use. 2. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product correction notice and share a copy of this notice. 3. POST a copy of this notification in your storeroom where the product is stored 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmbfieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product." Additional Information: "For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332."