LIFEPAK 35 ECG cable REF 11111-000041
FDA device recall Z-1102-2025 · posted 2025-02-05 · Open, Classified
Recall details
- Recalling firm
- Physio-Control, Inc.
- Reason for recall
- Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- DSA
- Quantity affected
- 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.
- Date initiated
- 2025-01-21
- Date posted
- 2025-02-05
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK® ECG Cables (K240377) | Stryker Physio-Control | 2024-05-07 |