Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Covidien LP (formerly Nellcor Puritan Bennett Inc.) appears in FDA public data with 7 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1181-2016, Class II) was initiated on January 15, 2016.
Summary
- Total Recalls
- 7 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1181-2016 | Class II | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide contin | January 15, 2016 |
| Z-2329-2015 | Class I | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal | July 16, 2015 |
| Z-2267-2015 | Class II | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check | June 29, 2015 |
| Z-2268-2015 | Class II | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen | June 29, 2015 |
| Z-1950-2015 | Class I | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3. | May 8, 2015 |
| Z-1951-2015 | Class I | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended fo | May 8, 2015 |
| Z-1058-2015 | Class II | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan Be | January 12, 2015 |