—#188496

Product

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

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
PMA numbers: P160029
Affected lot / code info: Lot Y111220-01

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Philips North America LLC
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2021-07-16
Posted by FDA: 2021-09-03
Terminated: 2023-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188496. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.