LIFEPAK 35 ECG Cable (Physio-Control) – incorrect instructions (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LIFEPAK 35 ECG cable REF 11111-000041
Brand
Physio-Control, Inc.
Lot Codes / Batch Numbers
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
Products Sold
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
Physio-Control, Inc. is recalling LIFEPAK 35 ECG cable REF 11111-000041 due to Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Recommended Action
Per FDA guidance
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 RSRecall@Stryker.com. 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: rsdevicetracking@stryker.com 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 RSRecall@Stryker.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026