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U.S. Department of Health and Human Services

Class 1 Device Recall Puritan Bennett

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  Class 1 Device Recall Puritan Bennett see related information
Date Initiated by Firm October 01, 2014
Date Posted October 28, 2014
Recall Status1 Terminated 3 on May 02, 2016
Recall Number Z-0112-2015
Recall Event ID 69320
510(K)Number K131252  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Covidien Puritan Bennett 980 Ventilator, Rx ONLY.

Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Code Information 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, and 35B1400543.
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett Inc. (dba Covidien LP)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact
303-530-6100
Manufacturer Reason
for Recall		 A software issue may lead to ventilator inoperative situations.
FDA Determined
Cause 2		 Software design
Action The firm sent Urgent: Field Correction Action letters, dated October 3, 2014, to consignees. The letter identified the affected product and the reason for the recall. Customers were provided actions to be taken, as well as, important safety reminders. The letter informed customers that they may continue to use their ventilators pending the software correction as long as two gas sources are connected to the ventilator at all times. Customers are to complete the attached acknowledgement and receipt form and fax it to Covidien at the number provided. For further assistance, customers are to contact the Technical Support Department at 1-800-255-6774.
Quantity in Commerce 324 units
Distribution Worldwide Distribution -- USA, including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, WI; and, the countries of Canada, Mexico, Saudi Arabia, South Africa, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = COVIDIEN
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