—#196268

Product

Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115

FDA product code: IME — Pack, Hot Or Cold, Reusable
Device class: Class 1
Medical specialty: Physical Medicine
Affected lot / code info: All lots

Why it was 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 .

Root cause (FDA determination)

Pending

Action the firm took

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."

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: nationwide and Canada

Timeline

Recall initiated: 2022-09-28
Posted by FDA: 2022-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.