Z-2360-2020 Class II Terminated
FDA device recall Z-2360-2020 was initiated by Physio-Control, Inc. on April 24, 2020 and is designated Class II. Reason for recall: Packaging of infant child reduced energy electrodes was not properly sealed. The recall status is terminated (terminated July 27, 2023). Affected quantity: 6732.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- April 24, 2020
- Termination Date
- July 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6732
Product Description
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.
Reason for Recall
Packaging of infant child reduced energy electrodes was not properly sealed.
Distribution Pattern
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.
Code Information
Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date