Recall Z-0188-2023 ยท IME Pack, Hot Or Cold, Reusable
Cardinal Health 200, LLC
Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
| Date | Nov 7, 2022 (initiated Sep 28, 2022) |
| Status | Open, Classified |
| Reason | 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 . |
| Root cause | Pending |
| Action | 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 614-65 |
| Quantity | 1209260 units |
| Distribution | nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.