FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
- Recall number
- Z-0543-2016
- Recalling firm
- Philips Electronics North America Corporation
- Product
- Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
- Status
- Terminated
- Initiated
- 2015-11-20
- Posted
- 2015-12-24
- Terminated
- 2017-08-07
- Reason
- Heel warmers may cause first and second degree burns.
- Root cause
- Labeling design
- Action
- Cardial Health was notified of the recall via letter on 11/20/2015. Cardinal Health notified all of their customers as of 12/1/2015. Philips instructed Cardinal Health do take the following steps: 1.) Check for and destroy any inventory of Cardinal Health Tiny Toes. 2.) Complete the Distributor Reply Form included in this letter to document this action. Fax to Philips Healthcare at +1 404-855-4900. Please do not return any product to Philips. 3.) Determine which of your customers may have affected product. 4.) Ask your customers to follow the instructions in the section entitled: ACTIONS FOR CARDINAL HEALTH CUSTOMERS/USERS TO TAKE. 5.) As you receive signed Customer Reply Forms from your customers, please forward a running monthly summary to us. Please email the summary to Jennifer Maglio at jennifer.maglio@philips.com. To maintain complete documentation, please retain your customers completed reply forms. Philips may request access to particular reply forms to respond to an audit inquiry. Actions for Cardinal Health Customers to Take: 1.) Discontinue use of Cardinal Health Tiny Toes. 2.) Check for any inventory of Cardinal Health Tiny Toes. 3.) Destroy all products on hand (eg. by activating or puncturing each unit). 4.) Complete and sign the Customer Reply Form provided in this letter or Cardinal Healths version thereof, to notify Cardinal Health of how many Cardinal Health Tiny Toes were destroyed. Submit your signed reply form only after you have completed all steps
- Quantity
- 7,327,100 individual units
- Distribution
- Moberly, MO
- Lot, serial or model codes
- All product in distribution
- 510(k) numbers
- ["K936084"]
- PMA numbers
- not on file
- Product code
- IMD
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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