Z-1102-2025Class II

LIFEPAK 35 ECG cable REF 11111-000041

Name: Z-1102-2025 LIFEPAK 35 ECG cable REF 11111-000041
Creator: Physio-Control, Inc.
Published: 2025-01-21
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2025-01-21 / Open, Classified / root cause: labeling and UDI

FDA source

Physio-Control, Inc. began a recall of LIFEPAK 35 ECG cable REF 11111-000041 on 2025-01-21. FDA classified it as Class II and gives the reason as "Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1102-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-21
Posted: 2025-02-05
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 35 ECG cable REF 11111-000041
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Reason for recall: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Root cause tag: labeling and UDI
FDA 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 [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].
Quantity in commerce: 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.
Product codes and lots: Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1102-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1102-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05

Product code DSA

K240377Class IILIFEPAK® ECG CablesStryker Physio-Control / cleared 2024-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)