Reported Nov 18, 2020 · Ongoing
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU)…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Series - Product Usagefor use on patient population sizes from Neonatal (NICU) through Adult who require respiratory
- support or mechanical ventilation SKU
106 of 106 codes
980X1ENDIUU980X1ENDIUU980X3FRAIQC980X3DEDRAC980X3ENNISB980X3NLDRAC980X3PLDIPC980X3ESDIEC980X3ITDIEC980X3JADIJJ980X3SVAIQC980U3ENASAA980U1ENDICU980U1FRDICU980X3ENDRAC980X1FRDISS980A3ENNISB980X1PLDIPC980X3SKNISC980U3ESDIUU980X1DEDISS980X3DEDISS980X3HUNISC980X3ENDIPP980X1BGDRAC980X1ENDRAC980X1NLDRAC980A1ENNISB980X3TRDRAC980X3CSNISC980U3ESDIUC980U1ENASAA980X1JADIJJ980X1FRAIQC980X1ENDIPC980X1ENNISB980X1ESDIEC980X1ITDIEC980X1PTDIPC980X1DEDRAC980X1TRDRAC980X3RODRAC980S1ENDICU980X3RUDRAC980U1ESDIUU980U3ESDIUA980X3SRDRAC980X1ENDIPP980U1ESDIUC980X3ENDIUU980X3ENDIJI980X1SKNISC980X3PTDIPC980U1ESDIUA980U3PTDIUNA980X1DAAGAC980X1FIAGAC980X1NOAGAC980X1SVAGAC980X3ENAIQC
- Lot codes and dates
- serial Numbers
2,716 of 2,716 codes
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
- serial Numbers
- Amount recalled
- 23,329 units total:. US 12,956; OUS 10,405
Where it was sold
- Nationwide
Why it was recalled
In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,
This product could cause temporary or reversible health problems — stop using it.
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