Z-0191-2023 Class II Ongoing
FDA device recall Z-0191-2023 was initiated by Cardinal Health 200, LLC on Sep 28, 2022 and is designated Class II. 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 . The recall status is ongoing. Affected quantity: 414194 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2022
- Initiation Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 414194 units
Product Description
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
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 Pattern
nationwide and Canada
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0191-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026