LIFEPAK 35 ECG cable recall
LIFEPAK 35 ECG cable REF 11111-000041
Why was LIFEPAK 35 ECG cable recalled?
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
- Product
- LIFEPAK 35 ECG cable REF 11111-000041
- Recalling firm
- Physio-Control, Inc.
- Quantity
- 245 units
- 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.
- Recall date
- February 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)