# FDA recall Z-1102-2025

> **Physio-Control, Inc.** · Class II · device recall initiated 2025-01-21.

## Product

LIFEPAK 35 ECG cable REF 11111-000041

## Reason for recall

Product shipped with incorrect IFU.  IFU does not include proper cleaning/disinfection instructions

## Distribution

U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.

## Key facts

- **Recall number:** Z-1102-2025
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-21
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2025

## Citation

> AI Analytics. FDA recall Z-1102-2025. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1102-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*