Recall Z-2360-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
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 respon
| Date | Apr 24, 2020 |
| Status | Terminated |
| Reason | Packaging of infant child reduced energy electrodes was not properly sealed. |
| Root 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 the |
| Quantity | 6732 |
| 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 countr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022732 | INFANT/CHILD REDUCED ENERGY ELECTRODES Medtronic Physio-Control Corp., Dec 13, 2002 |