FDA-Device2025-02-12Class II
LIFEPAK 35 ECG cable REF 11111-000041
Physio-Control, Inc.
Hazard
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Sold states
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.
Affected count
245 units
Manufactured in
11811 Willows Rd Ne, Redmond, WA, United States
Products
LIFEPAK 35 ECG cable REF 11111-000041
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2025Don't want to check this manually?
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