Device Recall PadPro

Lot Numbers: Y011813-09, Y040612-16, Y061214-15, Y090712-04, Y012714-08, Y040715-02, Y06291501, Y091914-07, Y013012-04, Y04291601, Y072012-14, Y100412-08, Y020713-13, Y050313-10, Y072513-04,  Y103114-03, Y022814-09, Y050412-08, Y07291601, Y110912-12, Y03151701, Y050814-15, Y08031702, Y11131501, Y031715-11, Y05251701, Y081314-03, Y112414-03, Y032513-16, Y06071601, Y08231601, Y121613-07 Y03271501, Y060812-04, Y090514-11 & Y12181501.

Cardiovascular Devices

3

No

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).

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 || 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.).

Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501.

Cardiovascular Devices

3

No

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).

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H || 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.).

Lot Numbers:  Y013114-14 Y04191607 Y061413-09 Y081513-07 Y101212-03 Y020714-08 Y04201507 Y06151504 Y081712-39 Y101413-12 Y021413-09 Y042514-10 Y061914-14 Y082212-13 Y10231528 Y021712-01 Y042712-06 Y06261516 Y08281506 Y10231529 Y030113-12 Y05041703 Y071213-13 Y090313-12 Y110714-08 Y03041604 Y05081508 Y071814-11 Y091914-13 Y112414-04 Y031414-04 Y051414-07 Y07191604 Y09241503 Y112613-03 Y032513-03 Y052914-08 Y072712-03 Y092612-16 Y112912-13 Y032612-05 Y060412-05 Y07271508 Y100212-01 Y11301601 Y040314-07 Y060713-12 Y080113-05 Y100713-02 Y121714-09 Y040813-01 Y06071704 Y081114-05 Y10071602 Y121813-09 Y041712-02

Cardiovascular Devices

3

No

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).

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M || 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.).

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.

Cardiovascular Devices

3

No

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).

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.).

Lot Code Y092012-21, Manufacture Date 10/10/2012;  Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013;  Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013

Cardiovascular Devices

3

No

Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.

PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. || The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications