FDA Device recall Z-0189-2023
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A 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-0189-2023 |
| 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 INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
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 | 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-0189-2023%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.