—#162060

Product

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K002280
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below: 1. Email to: padpro2602@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: 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).

Timeline

Recall initiated: 2018-02-23
Terminated: 2020-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.