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Terminated

Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

FDA Recall Z-0180-2015 · Posted 2014-12-09

Recalling FirmNellcor Puritan Bennett Inc. (dba Covidien LP)
Recall StatusTerminated
Product CodeCBK
Date Initiated2014-10-01
Date Terminated2016-07-01
Product Quantity324 units

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.

Firm Action

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.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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