Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Reported: November 16, 2022 Initiated: September 28, 2022 #Z-0185-2023
Product Description
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
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 .
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 1915308 units
- Distribution
- nationwide and Canada
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115. Recalled by Cardinal Health 200, LLC. Units affected: 1915308 units.
Why was this product recalled? ▼
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 .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0185-2023.
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