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 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.

Description of Event or Problem

IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. THE CONTENTS LANDED ON THE BABY¿S SWADDLE AND WAS IMMEDIATELY CLEANED BY OTHER STAFF. THE INFANT IS DOING FINE.