Reported Nov 5, 2014 · Terminated

Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital…

Nellcor Puritan Bennett Inc. (dba Covidien LP)

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nellcor Puritan Bennett Inc. (dba Covidien LP) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214

Is this the product you have?

  • 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.
Lot codes and dates
  • Model number PB980 Ventilator

    214 of 214 codes

    • 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
Amount recalled
324 units

Where it was sold

Why it was recalled

Stop using this product now

A software issue may lead to ventilator inoperative situations.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 2, 2016 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.