FDA Device recall Z-0192-2023
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A by Cardinal Health 200, citing 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 .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0192-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-28 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
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 .
Identifiers
| code_info | UDI/DI (01)30888499004898, All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.