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Lower risk Medical device recall · FDA · Published April 24, 2020

Physio-Control Infant Child Starter Kits Recall: Packaging Not Properly Sealed

Physio-Control recalls Infant Child Starter Kits (part 3202784-009) with improperly sealed packaging for infant/child defibrillation electrodes, which could lead to contamination. Affected kits were sold from August 2017 to October 2019.

🇺🇸 FDA recall #Z-2360-2020Medical devicePhysio-Control ›
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Recalling firmPhysio-Control, Inc.11811 Willows Rd Ne · Redmond, WA 98052-2003
✎ GovInfoNow plain-language explainer

Physio-Control is recalling Infant Child Starter Kits with part number 3202784-009 that contain infant/child reduced energy defibrillation electrodes. The recall is due to packaging not being properly sealed, which could lead to contamination of the electrodes. Read more at govinfonow.com/recall/65311-physio-control-infant-child-starter-kits-recall-packaging-not-properly.

Source Summary by GovInfoNow · govinfonow.com/recall/65311-physio-control-infant-child-starter-kits-recall-packaging-not-properly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2360-2020

Cite this page

“Physio-Control Infant Child Starter Kits Recall: Packaging Not Properly Sealed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65311-physio-control-infant-child-starter-kits-recall-packaging-not-properly. Based on FDA recall #Z-2360-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2020%22&limit=1).

Physio-Control, Inc. recalled Infant Child Starter Kits containing reduced energy defibrillation electrodes due to improperly sealed packaging, according to a Food and Drug Administration announcement on April 24, 2020.

How to tell if you have it

  • Brand: Physio-Control
  • Product: Infant Child Starter Kits, Part Number: 3202784-009
  • Contents: Infant/Child Reduced Energy Defibrillation Electrodes
  • Compatible devices: LIFEPAK 1000, LIFEPAK 500, and LIFEPAK CR Plus/EXPRESS defibrillators
  • Manufacture dates: August 2017 through October 2019
  • Quantity: 6732 units

The hazard

The packaging of the infant child reduced energy electrodes was not properly sealed, according to the FDA.

Context

GovInfoNow's records show Physio-Control, Inc. has 17 other recalls on record since October 27, 2017. Other recent recalls include LIFEPAK 15 Defibrillators (April 13, 2026), Infant/Child Defibrillator Electrodes (January 21, 2026), and LIFEPAK 1000 Defibrillators (July 22, 2025). Other recent recalls of similar products include Medline Pediatric Catheter Kits (December 24, 2025) and Medline Convenience Kits (June 12, 2026).

How to tell if you have this one

Check for the part number 3202784-009 on the Infant Child Starter Kits. These kits were sold between August 2017 and October 2019 and contain electrodes for LIFEPAK 1000, LIFEPAK 500, or LIFEPAK CR Plus/EXPRESS defibrillators.

  • Brand
    Physio-Control
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-2359-2020Infant/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.; Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date118689
Z-2360-2020Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, 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.; Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date6732
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Seal

    Inspect the packaging for proper sealing; if unsealed, do not use the electrodes.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

1. Firm started the recall: Apr 24, 202012. FDA classified it Class II: Jun 11, 202023. Published in FDA’s Enforcement Report: Jun 17, 202034. FDA terminated the recall: Jul 27, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2360-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2360-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA