Recalls / —

—#141972

Product

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

FDA product code

IMD — Pack, Hot Or Cold, Disposable

Device class

Class 1

Medical specialty

Physical Medicine

510(k) numbers

K936084

Affected lot / code info

All product in distribution

Why it was recalled

Heel warmers may cause first and second degree burns.

Root cause (FDA determination)

Labeling design

Action the firm took

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

Recalling firm

Firm

Philips Electronics North America Corporation

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

Moberly, MO

Timeline

Recall initiated

2015-11-20

Posted by FDA

2015-12-24

Terminated

2017-08-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #141972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.