FDA Device recall Z-0187-2018
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRES…
- FDA Device
- Class I
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class I recall of LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRES… by Physio Control, citing the infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0187-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-10-27 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Physio Control |
| Distribution | US |
Product
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
Reason
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Identifiers
| code_info | 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2018%22
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