Reported Dec 26, 2018 · Terminated
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980…
Covidien LLC
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: COVIDIEN LLC · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- Puritan
- Bennett 980 (PB980) ventilator seriesPuritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980
- Universal Ventilator Product UsageThe Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the
- followingtypes of ventilator supportPositive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/ Control, SIMV or Spontaneous modes of ventilation
- Lot codes and dates
- Serial Numbers35B1300001 through 35B1300051 35B1400003 through 35B1402216 35B1500001 through 35B1502227 35B1600001 through 35B1601408 35B1700001 through 35B1702519 35B1800001 through 35B1801541 35B1400001 35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242 35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089
- Amount recalled
- 9,593
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Using this product could cause serious injury, illness or death — stop using it now.
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