LIFEPAK 35 ECG cable REF 11111-000041 recallZ-1102-2025 · Physio-Control, Inc. · initiated Jan 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Physio-Control, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
FDA root cause category: Labeling Change Control
What the company is doing
On 01/21/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that Stryker discovered that an incorrect version of the Instructions for Use (IFU) for the 3-wire extended precordial ECG cable for the LIFEPAK 35 were distributed to customers. This version did not include information regarding disinfection of the 3-wire cable. Customer are instructed to: 1. Immediately check internal inventory to locate the product listed on the attached business reply form. 2. Remove and quarantine any affected product from use. 3. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, email the enclosed Business Reply Form (BRF) by January 31st, 2025 date, to [email protected]. 4. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for the return and replacement of their product(s). 5. Maintain awareness of this communication internally until all required actions have been completed within their facility. Ensure this letter is kept with the affected device until replacement. 6. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: [email protected] b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/ If you have any questions or concerns, contact Customer Service +1 800 442 1142 or by email [email protected].
Recall details
- Recall number
- Z-1102-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 21, 2025
- Posted by the FDA
- Feb 5, 2025
- Recalling firm
- Physio-Control, Inc.
- Quantity
- 245 units
- Product code
- DSA
- FDA submissions
- K240377
- 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.
Product description
LIFEPAK 35 ECG cable REF 11111-000041
Code information (models, lots, serial numbers)
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ASSY, CABLE, ECG, 15 LEAD, 3 WIRE PRECOR 11111Physio-Control, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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