Infant/Child Reduced Energy Defibrillation Electrodes — Class II medical device recall Z-2359-2020
Terminated recall by Physio-Control, Inc., reported 2020-06-17, distributed nationwide. Packaging of infant child reduced energy electrodes was not properly sealed.
| Recall number | Z-2359-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2020-04-24 |
| Classified | 2020-06-11 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2023-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 118,689 |
| Model numbers | 3202380-006 |
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.
Reason for recall
Packaging of infant child reduced energy electrodes was not properly sealed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2359-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.