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Open, Classified

Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A

FDA Recall Z-0189-2023 · Posted 2022-11-07

Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeIME
Date Initiated2022-09-28
Product Quantity499997 units

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 .

Firm 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 [email protected], 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: [email protected] or call 800-292-9332."

Root Cause

Pending

Distribution Pattern

nationwide and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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