Recall Z-0190-2023— Cardinal Health 200, LLC
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2022-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A. 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 ..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-28
- Firm location
- Waukegan, IL, United States
Product description
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 .
Data sourced from openFDA. This site is unofficial and independent of the FDA.