Z-0186-2018Class I

LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes...

Name: Z-0186-2018 LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes...
Creator: Physio-Control, Inc.
Published: 2017-10-27
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2017-10-27 / Terminated / root cause: manufacturing process

FDA source

Physio-Control, Inc. began a recall of LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK... on 2017-10-27. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0186-2018
Classification: Class I
Status: Terminated
Initiated: 2017-10-27
Posted: 2017-12-12
Terminated: 2019-06-12
Recalling firm: Physio Control, Inc.
Product: LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm Physio Control, initiated their field action on 10/27/2017 by issuing a press release. The firm followed this with a recall notice dated 10/23/2017, to the direct consignees on 11/03/2017. The letter described the product, explained the problem and provided the following instructions: Quarantine the affected lots;contact Physio-Control at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday to arrange for replacement of your unused electrodes and "Upon receipt of this notification, post a copy of the enclosed Correct Electrode and Packaging Labeling with each of your AEDs, which shows the correct placement of the electrodes." Physio_Control will provide replacement products for all unused affected Electrodes. Should you have any questions about this Product Recall, please contact us at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday.
Quantity in commerce: 14,219 units in total
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.
Product codes and lots: 713609, 717912, 713904, 718033, 715008, 719323

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0186-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0186-2018	Class I	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-12
Z-0187-2018	Class I	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-12

Product code MKJ

K022732Class IIIInfant/child Reduced Energy ElectrodesMedtronic Physio-Control Corp. / cleared 2002-12-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)