Class 2 Device Recall Infant/Child Reduced Energy Defibrillation Electrodes

• Date Initiated by Firm: April 24, 2020
• Create Date: June 11, 2020
• Recall Status: Terminated on July 27, 2023
• Recall Number: Z-2359-2020
• Recall Event ID: 85173
• 510(K)Number: K022732
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.
• Code Information: Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date
• Recalling Firm/ Manufacturer: Physio-Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: 425-867-4000
• Manufacturer Reason for Recall: Packaging of infant child reduced energy electrodes was not properly sealed.
• FDA Determined Cause: Packaging change control
• Action: Urgent Medical Device Safety Notice & Correction Action notices dated 04/24/20 were mailed by Stryker to customers. Customers were asked to inspect their inventory to identify any electrode packages that have compromised seals. Remove from inventory and destroy any product suspected to exhibit this condition. Complete the attached acknowledgement form and return the completed form to your distributor to confirm your receipt and understanding of this information. Your distributor will provide you with replacement electrodes. Distributors were asked to communicate recall information to their customers by using an editable Customer communication packet. The End Customer Acknowledgement and Receipt Form should be edited to include remittance information for your organization (recommend email address and/or fax number) in the editable fields at the bottom of the form so that the forms completed by your customers will be returned to you. Upon receipt of End Customer Acknowledgement and Receipt Form from end customers, consolidate information within a copy of the enclosed Acknowledgement and Receipt Form and return to Stryker as directed. Stryker will ship replacement electrodes to distributor upon receipt for you to distribute to your end customers. Customers with additional questions were encouraged to call 1-800-787-9537, option 2, 8:00 A.M. to 6:00 P.M. (Eastern Time), Monday - Friday.
• Quantity in Commerce: 118689
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA, AZ, NJ, MA, MO, NC, MD, OH, PA, CA, IA, VA, WI, MN, SC, IN, DE, KY, MT, AL, MS, NM, ME, OK, WV, SD, RI, ND, LA, AR, HI, DC, KS, NE, VT, OR, AK, NV, UT, WY, NH, PR, ID, and the countries of CA, ZA, TW, AU, JP, HK, MA, NZ, SG, BR, NL, PA, SA, AR, CL, TH, SV, CR, TR, GU, MY, VI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.