BEUDAMED
    FDA Recall Terminated

    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

    Recall: Z-2427-2021 · Initiated July 16, 2021

    Recall

    Recall Number
    Z-2427-2021
    Event Number
    88361
    Firm
    Philips North America LLC
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 16, 2021
    Posted
    September 3, 2021
    Terminated
    May 12, 2023
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

    Reason

    Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient

    Action

    On July 26, 2021, Phillips issued an "Urgent Medical Device Removal" notification to affected consignees. On August 23, 2021, Phillips issued a revised "Urgent Medical Device Removal notification to update their recall strategy concerning replacement infant/child smart pads cartridges. In addition to informing consignees about the recalled product, Phillips asked consignees to take the following actions: Action 1: If needed, contact your distributor to request a replacement. Customers who purchased their pads cartridges directly from Philips will receive their replacements without any further action on their part. Customers who purchases their pads cartridges from a distributor should contact that distributor to request replacement. Replacement pads cartridges may not be available immediately, therefore, refer to Action 2, below. Action 2: Determine if the Infant/Child SMART Pads may remain in service until replaced. 1. Philips, or your Philips Distributor, will supply a replacement of all M5072A Infant/Child SMART Pads Cartridges from Lot Number Y111220-01. 2. If the Infant/Child SMART Pads Cartridge is still inside the pouch, then it can remain in service until replaced. While waiting to receive the replacement, customers should keep the Infant/Child SMART Pads Cartridge inside the outer pouch until the cartridge is replaced, or until it is needed for therapy. The reason is because the pouch correctly identifies the cartridge as intended for infant/child patients. (Figure 7). 3. If the Infant/Child SMART Pads Cartridge has been removed from the outer pouch, and if the protective cover shows a drawing of pads placement for a child s chest and back, then it can remain in service until replaced. The reason is because the protective cover has the correct image with the image of a child s chest and back. (Figure 8). 4. If the Infant/Child SMART Pads Cartridge has been removed from the outer pouch, and if the protective cover shows a dra

    Distribution

    Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdom, and Uruguay

    Quantity

    19,840 units