NOVAPLUS INFANT HEEL WARMER SQUEEZE

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 (B)(6), 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.

Description of Event or Problem

DURING A VIRTUAL IN-SERVICE WITH THE TEAM AT LA GENERAL MED CENTER, THE CUSTOMER IS REPORTING THAT THEY HAD INFANT HEEL WARMERS BURST WHILE ATTEMPTING TO ACTIVATE THEM. NO ONE WAS INJURED AS THESE WERE CONTROLLED TESTS.

Additional Manufacturer Narrative

THIS 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.