FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
- Recall number
- Z-2147-2023
- Recalling firm
- Cardinal Health 200, LLC
- Product
- NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
- Status
- Open, Classified
- Initiated
- 2023-06-16
- Posted
- 2023-07-17
- Terminated
- not on file
- Reason
- Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
- Root cause
- Process control
- Action
- Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 06/16/2023 for delivery n 06/19/2023 by FedEx priority overnight. The notice explained the problem, risks, and requested the following: "Actions Required: 1. REVIEW your inventory for the affected product code and lot. Location of product code and lot are shown in above listed table and below example labeling. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 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
- 44,500 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056
- 510(k) numbers
- ["K961154"]
- PMA numbers
- not on file
- Product code
- MPO
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28