NOVAPLUS INFANT HEEL WARMER SQUEEZE

Additional Manufacturer Narrative

THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

Description of Event or Problem

CUSTOMER REPORTED THAT THE INFANT HEEL WARMERS HAVE MALFUNCTIONED. WHEN YOU SQUEEZE THEM TO ACTIVATE, THEY BREAK OPEN. YESTERDAY THE MOTHER WAS SITTING CLOSE TO THE NURSE WHEN THIS HAPPENED AND IT SPRAYED ALL OVER HER FACE AND IN HER EYES. MOTHER USED THE EYE WASH STATION. THERE WAS NO INJURY OR MEDICAL CARE REQUIRED.

Additional Manufacturer Narrative

CARDINAL HEALTH HAS RECEIVED AN INCREASE IN BURST/LEAKING COMPLAINTS REGARDING THE NOVALPLUS INFANT HEEL WARMER WITH TAPE. CUSTOMER COMPLAINTS HAVE NOTED RUPTURING AND BURSTING OF THE DEVICE WHEN ACTIVATION IS ATTEMPTED, MAKING THE DEVICE UNUSABLE AND IN MANY CASES CAUSING THE CONTENTS INSIDE THE POUCH TO LEAK AND CONTACT CLINICIANS, PATIENTS, AND OTHER INDIVIDUALS OR SURFACES IN PROXIMITY. SAMPLES RETURNED TO CARDINAL HEALTH FROM CUSTOMERS HAVE BEEN EVIDENCED TO HAVE AN INCOMPLETE TOP SEAL, RESULTING IN THE MALFUNCTION. THERE HAVE BEEN NO REPORTABLE ADVERSE EVENTS/INJURIES ASSOCIATED WITH V11460-010, LOT V2S056. CARDINAL HEALTH HAS HALTED DISTRIBUTION OF THE NOVALPLUS INFANT HEEL WARMER W/TAPE FOR LOT NUMBER V2S056 AND INITIATED A VOLUNTARY RECALL ON JUNE 16, 2023.