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U.S. Department of Health and Human Services

Class 2 Device Recall NovaPlus Infant Heel Warmer with Tape

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  Class 2 Device Recall NovaPlus Infant Heel Warmer with Tape see related information
Date Initiated by Firm June 16, 2023
Date Posted July 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-2147-2023
Recall Event ID 92529
510(K)Number K961154  
Product Classification Infant heel warmer (chemical heat pack) - Product Code MPO
Product NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Code Information UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
847-887-5500
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 44,500 units
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MPO and Original Applicant = BAXTER HEALTHCARE CORP.
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