FDAClass IIJune 17, 2020

Infant Child Starter Kits recall

Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000…

Why was Infant Child Starter Kits recalled?

Packaging of infant child reduced energy electrodes was not properly sealed.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date

Product
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000…
Recalling firm
Physio-Control, Inc.
Quantity
6732
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 date
June 17, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls