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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health

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  Class 2 Device Recall Cardinal Health see related information
Date Initiated by Firm September 28, 2022
Date Posted November 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0191-2023
Recall Event ID 90955
Product Classification Pack, hot or cold, reusable - Product Code IME
Product Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
Code Information All lots
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact Market Action Team
800-292-9332
Manufacturer 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 .
FDA Determined
Cause 2		 Pending
Action Cardinal Health sent an URGENT:MEDICAL DEVICE PRODUCT CORRECTION on 10/03/2022 by overnight mail. The notice explained the issue and requested the following: "Actions Required: 1. COMMUNICATE with all personnel that utilize these gel packs regarding appropriate use. 2. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product correction notice and share a copy of this notice. 3. POST a copy of this notification in your storeroom where the product is stored 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmbfieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product." Additional Information: "For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332."
Quantity in Commerce 414194 units
Distribution nationwide and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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