LIFEPAK — Class I medical device recall Z-0187-2018
Terminated recall by Physio-Control, Inc., reported 2017-12-20, distributed nationwide. The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF
| Recall number | Z-0187-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2017-10-27 |
| Classified | 2017-12-12 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2019-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IT, JP, LV, MX, NL, NO, NZ, PA, PL, PT, QA, SA, SE, SG, SI, ZA |
| Quantity | 14,219 units |
| Model numbers | 11101-000017, 3202784-009 |
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 for recall
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.
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-0187-2018. 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.