Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, 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.
- Company
- Physio Control, Inc.
- Recall Initiated
- April 24, 2020
- Terminated
- July 27, 2023
- Recall Number
- Z-2360-2020
- Quantity
- 6732
- Firm Location
- Redmond, WA
Reason for Recall
Packaging of infant child reduced energy electrodes was not properly sealed.
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.
Lot / Code Info
Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date
Root Cause
Packaging change control
Action Taken
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.