Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204

FDA device recall Z-0186-2023 · posted 2022-11-07 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

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 .

Action taken

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."

Root cause

Pending

Status

Open, Classified

Product code

IME

Quantity affected

409738 units

Distribution

nationwide and Canada

Date initiated

2022-09-28

Date posted

2022-11-07

Location

Waukegan, IL