Medical Device Recall: Z-0180-2015

FDA Recalls dataset · Firm: Nellcor Puritan Bennett Inc. (dba Covidien LP) · Status: Terminated

Recall Action Class: N/A Date Initiated: 2014-10-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0180-2015.

Recall Res Number
Z-0180-2015
Recalling Firm / Manufacturer
FEI Number
2936999
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2014-10-01
Date Posted
2014-12-09
Date Terminated
2016-07-01
Product Code
CBK
Event Number
69324
Product Quantity
324 units
Product Description Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

Reason for Recall Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.

Action Details Update: Consignees were notified on 12/11/14 of strategy change after Covidien sent an Urgent Field Safety Corrective Action notification with instructions dated September 2014 via traceable courier to affected consignees. The letter identifed the affected product, problem and actions to be taken. Consignees were instructed to complete the attached verification form and fax it to the Covidien RMS contact indicated on the form. If you need further assistance, contact the Technical Support Department @ 1-800-255-6774, option 4, then option 1.

Distribution Pattern Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.

Code Information / Serial Numbers Model number PB980 Ventilator:35B1400143, 35B1400684, 35B1400627, 35B1400708, 35B1400398, 35B1400482,  35B1400491, 35B1400512, 35B1400601, 35B1400121, 35B1400568, 35B1400590, 35B1400595, 35B1400599, 35B1400606, 35B1400106, 35B1400146, 35B1400169, 35B1400226, 35B1400260, 35B1400270, 35B1400263, 35B1400351, 35B1400373, 35B1400400, 35B1400401, 35B1400608, 35B1400089, 35B1400112, 35B1400683, 35B1400685, 35B1400678, 35B1400118, 35B1400114, 35B1400355, 35B1400144, 35B1400300, 35B1400379, 35B1400412, 35B1400472, 35B1400489, 35B1400490, 35B1400492, 35B1400493, 35B1400499, 35B1400500, 35B1400501, 35B1400502, 35B1400507, 35B1400577,  35B1400207, 35B1400211, 35B1400216, 35B1400222, 35B1400225, 35B1400231, 35B1400267, 35B1400312, 35B1400323, 35B1400340, 35B1400383, 35B1400128, 35B1400363, 35B1400459, 35B1400589, 35B1400616,  35B1400637, 35B1400483, 35B1400311, 35B1400447,  35B1400648, 35B1400651, 35B1400654, 35B1400662,  35B1400686, 35B1400692, 35B1400175, 35B1400294, 35B1400436, 35B1400485, 35B1400586, 35B1400644,  35B1400687, 35B1400689, 35B1400694, 35B1400700,  35B1400661, 35B1400676, 35B1400693, 35B1400732,  35B1400734, 35B1400736, 35B1400737, 35B1400742, 35B1400280, 35B1400360, 35B1400471, 35B1400609,  35B1400674, 35B1400688, 35B1400755, 35B1400480,  35B1400675, 35B1400706, 35B1400771, 35B1400667,  35B1400704, 35B1400705, 35B1400727, 35B1400743,  35B1400279, 35B1400285, 35B1400262, 35B1400265, 35B1400259, 35B1400494, 35B1400403, 35B1400779, 35B1400783, 35B1400509, 35B1400724, 35B1400763, 35B1400767, 35B1400566, 35B1400768, 35B1400772,  35B1400791, 35B1400793, 35B1400817, 35B1400525, 35B1400796, 35B1400801, 35B1400809, 35B1400821,  35B1400828, 35B1400333, 35B1400366, 35B1400392,  35B1400440, 35B1400463, 35B1400478, 35B1400308,  35B1400347, 35B1400367, 35B1400396, 35B1400078,  35B1400099, 35B1400130, 35B1400155, 35B1400157, 35B1400158, 35B1400174, 35B1400176, 35B1400178, 35B1400180, 35B1400281, 35B1400315, 35B1400631, 35B1400635, 35B1400625, 35B1400653, 35B1400843, 35B1400847, 35B1400233, 35B1400271, 35B1400337, 35B1400350, 35B1400359, 35B1400368, 35B1400384, 35B1400468, 35B1400486, 35B1400495, 35B1400094, 35B1400236, 35B1400437, 35B1400438, 35B1400479, 35B1400496, 35B1400505, 35B1400506, 35B1400427, 35B1400511, 35B1400325, 35B1400462, 35B1400514, 35B1400536, 35B1400537, 35B1400544, 35B1400066, 35B1400200, 35B1400782, 35B1400829, 35B1400015, 35B1400110, 35B1400516, 35B1400517, 35B1400859, 35B1400013, 35B1400103, 35B1400167, 35B1400124, 35B1400007, 35B1400058, 35B1400083, 35B1400129, 35B1400132, 35B1400006, 35B1400079, 35B1400113, 35B1400116, 35B1400219, 35B1400163, 35B1400543.

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