Recall Z-1102-2025— Physio-Control, Inc.

Name: FDA recall Z-1102-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-21

Class II · Ongoing

Class II FDA medical device recall by Physio-Control, Inc., initiated 2025-01-21. It names one FDA 510(k) clearance: K240377. Product: LIFEPAK 35 ECG cable REF 11111-000041. Reason: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions.

Recalling firm: Physio-Control, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-21
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K240377 — LIFEPAK® ECG CablesStryker Physio-Control·cleared 2024-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LIFEPAK 35 ECG cable REF 11111-000041

Reason for recall

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

Data sourced from openFDA. This site is unofficial and independent of the FDA.