Cardinal Health INSULATED GEL PACK REUSABLE — Class II medical device recall Z-0190-2023
Ongoing recall by Cardinal Health 200, LLC, reported 2022-11-16, distributed nationwide. Users are being informed that the product should not be used on infants/neonates. A caution statement will be
| Recall number | Z-0190-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2022-09-28 |
| Classified | 2022-11-07 |
| Reported by FDA | 2022-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 649,213 units |
| Reason classes | labeling |
| Model numbers | 80304A |
Product
Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
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 .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0190-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.