Z-2359-2020Class II

Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000...

Name: Z-2359-2020 Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000...
Creator: Physio-Control, Inc.
Published: 2020-04-24
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2020-04-24 / Terminated / root cause: packaging

FDA source

Physio-Control, Inc. began a recall of Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and... on 2020-04-24. FDA classified it as Class II and gives the reason as "Packaging of infant child reduced energy electrodes was not properly sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2359-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-24
Posted: 2020-06-11
Terminated: 2023-07-27
Recalling firm: Physio Control, Inc.
Product: Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Packaging of infant child reduced energy electrodes was not properly sealed.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Urgent Medical Device Safety Notice & Correction Action notices dated 04/24/20 were mailed by Stryker to customers. Customers were asked to inspect their inventory to identify any electrode packages that have compromised seals. Remove from inventory and destroy any product suspected to exhibit this condition. Complete the attached acknowledgement form and return the completed form to your distributor to confirm your receipt and understanding of this information. Your distributor will provide you with replacement electrodes. Distributors were asked to communicate recall information to their customers by using an editable Customer communication packet. The End Customer Acknowledgement and Receipt Form should be edited to include remittance information for your organization (recommend email address and/or fax number) in the editable fields at the bottom of the form so that the forms completed by your customers will be returned to you. Upon receipt of End Customer Acknowledgement and Receipt Form from end customers, consolidate information within a copy of the enclosed Acknowledgement and Receipt Form and return to Stryker as directed. Stryker will ship replacement electrodes to distributor upon receipt for you to distribute to your end customers. Customers with additional questions were encouraged to call 1-800-787-9537, option 2, 8:00 A.M. to 6:00 P.M. (Eastern Time), Monday - Friday.
Quantity in commerce: 118689
Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA, AZ, NJ, MA, MO, NC, MD, OH, PA, CA, IA, VA, WI, MN, SC, IN, DE, KY, MT, AL, MS, NM, ME, OK, WV, SD, RI, ND, LA, AR, HI, DC, KS, NE, VT, OR, AK, NV, UT, WY, NH, PR, ID, and the countries of CA, ZA, TW, AU, JP, HK, MA, NZ, SG, BR, NL, PA, SA, AR, CL, TH, SV, CR, TR, GU, MY, VI.
Product codes and lots: Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2359-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2359-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-11
Z-2360-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)