Recall Z-0187-2018— Physio-Control, Inc.

Name: FDA recall Z-0187-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-27

Class I · Terminated

Class I FDA medical device recall by Physio-Control, Inc., initiated 2017-10-27, terminated 2019-06-12. It names one FDA 510(k) clearance: K022732. Product: LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.. Reason: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols..

Recalling firm: Physio-Control, Inc.
Classification: Class I
Status: Terminated
Initiated: 2017-10-27
Terminated: 2019-06-12
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODESMedtronic Physio-Control Corp.·cleared 2002-12-13

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(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.

Reason for recall

The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

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