ECG cable shipped with incomplete cleaning and disinfection instructions
Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a cardiac monitoring device with incomplete cleaning and disinfection instructions. While no illnesses or injuries have been reported, improper disinfection of reusable medical equipment poses a documented risk of cross-contamination and patient harm.
Plain-English summary
Physio-Control, Inc. is recalling 245 units of the LIFEPAK 35 ECG cable (Catalog Number 11111-000041, Lot/Serial Number 0224). The recalled product was shipped with instructions for use (IFU) that do not include proper cleaning and disinfection procedures.
Incomplete cleaning and disinfection instructions for medical devices used in direct patient care create a risk of improper device maintenance and potential cross-contamination between patients or multiple uses of the same device.
The LIFEPAK 35 ECG cable was distributed nationwide to healthcare facilities across California, Florida, Georgia, Iowa, Indiana, Kentucky, Maryland, Michigan, Missouri, Nebraska, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee, Texas, and Wisconsin.
The recalled product
- Product
- LIFEPAK 35 ECG cable REF 11111-000041
- Manufacturer
- Physio-Control, Inc.
- Hazard
- incomplete-instructions
- cross-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
Distribution
Distributed nationwide across the United States.
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