FDA Medical Device Recalls (openFDA)
Physio-Control, Inc.: LIFEPAK 35 ECG cable REF 11111-000041
- Recall number
- Z-1102-2025
- Recalling firm
- Physio-Control, Inc.
- Product
- LIFEPAK 35 ECG cable REF 11111-000041
- Status
- Open, Classified
- Initiated
- 2025-01-21
- Posted
- 2025-02-05
- Terminated
- not on file
- Reason
- Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
- Root cause
- Labeling Change Control
- Action
- 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.
- 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.
- Lot, serial or model codes
- Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
- 510(k) numbers
- ["K240377"]
- PMA numbers
- not on file
- Product code
- DSA
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28