Recall Z-1102-2025 · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Physio-Control, Inc.
LIFEPAK 35 ECG cable REF 11111-000041
| Date | Feb 5, 2025 (initiated Jan 21, 2025) |
| Status | Open, Classified |
| 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 C |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240377 | LIFEPAK® ECG Cables Stryker Physio-Control, May 7, 2024 |