LIFEPAK 35 ECG cable REF 11111-000041 — Class II medical device recall Z-1102-2025
Ongoing recall by Physio-Control, Inc., reported 2025-02-12, distributed nationwide. Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
| Recall number | Z-1102-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2025-01-21 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 245 units |
| UPC / GTIN / UDI-DI | 00883873834596 |
| Serial numbers | 0224 |
| Model numbers | 11111-000041 |
Product
LIFEPAK 35 ECG cable REF 11111-000041
Reason for recall
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
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-1102-2025. 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.