Z-0187-2023 Class II Ongoing
FDA device recall Z-0187-2023 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: 567475 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2022
- Initiation Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 567475 units
Product Description
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
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-0187-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026