FDAClass IIApril 4, 2018

Mini Infant < recall

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and…

Why was Mini Infant < recalled?

Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

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?

Lot Numbers: Y010713-02, Y03181603, Y051414-08, Y072012-12,Y09301601, Y012312-14, Y03201511, Y05151513, Y07251703, Y100314-14, Y013114-16, Y032513-17, Y052313-10, Y07271507, Y10061701, Y02151602, Y03251604, Y06011502, Y07271702, Y10071603, Y021712-02, Y03251605, Y061214-04, Y08101504, Y101413-06, Y02171701, Y032612-15, Y061412-06, Y08171703, Y101512-06, Y02261606, Y040314-08, Y06221508, Y082214-12, Y102714-11, Y022712-01, Y04041701, Y062714-10, Y08241505, Y111414-09, Y030113-13, Y041612-10, Y07061610, Y090613-11, Y11141607, Y030514-12, Y042712-07, Y07061702, Y091214-17, Y112912-14, Y030912-08, Y051013-06, Y071213-14, Y092012-28, Y120712-01, Y03181602, Y05111702, Y071814-12, Y09201703, Y121714-10 & Y121813-10.

Product
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and…
Recalling firm
ConMed Corporation
Quantity
18,720 units in total
Distribution
Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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