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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health Tiny Toes

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  Class 2 Device Recall Cardinal Health Tiny Toes see related information
Date Initiated by Firm November 20, 2015
Date Posted December 24, 2015
Recall Status1 Terminated 3 on August 07, 2017
Recall Number Z-0543-2016
Recall Event ID 72681
510(K)Number K936084  
Product Classification Pack, hot or cold, disposable - Product Code IMD
Product Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Code Information All product in distribution
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Sonja Luczyk
262-798-9802
Manufacturer Reason
for Recall		 Heel warmers may cause first and second degree burns.
FDA Determined
Cause 2		 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 in Commerce 7,327,100 individual units
Distribution Moberly, MO
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IMD and Original Applicant = OMNI THERM, INC.
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