FDA Medical devices recall ·
LIFEPAK 35 ECG cable recall
- Recall number
- Z-1102-2025
- Date
- (initiated January 21, 2025)
- Company / brand
- Physio-Control, Inc.
11811 Willows Rd Ne, Redmond, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 245 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LIFEPAK 35 ECG cable REF 11111-000041
Why was it recalled?
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
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.
States: California Florida Georgia Iowa Indiana Kentucky Maryland Michigan Missouri Nebraska Nevada New York Ohio Oregon South Carolina Tennessee Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1102-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.