Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x… recallZ-0192-2023 · Cardinal Health 200, LLC · initiated Sep 28, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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 .
FDA root cause category: Pending
What the company is doing
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."
Recall details
- Recall number
- Z-0192-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 28, 2022
- Posted by the FDA
- Nov 7, 2022
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 129412 units
- Product code
- IME
- Distribution
- nationwide and Canada
Product description
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
Code information (models, lots, serial numbers)
UDI/DI (01)30888499004898, All lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CARDINAL HEALTH 70304ACardinal Health 200, LLC · Pack, hot or cold, reusable1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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