Nellcor Puritan Bennett Inc. (dba Covidien LP)
Nellcor Puritan Bennett Inc. (dba Covidien LP) appears in FDA public data with 11 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-0112-2015, Class I) was initiated on October 1, 2014.
Summary
- Total Recalls
- 11 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0112-2015 | Class I | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institution | October 1, 2014 |
| Z-0180-2015 | Class I | Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDI | October 1, 2014 |
| Z-2234-2014 | Class II | Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled de | July 17, 2014 |
| Z-2235-2014 | Class II | Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controll | July 17, 2014 |
| Z-1809-2014 | Class II | Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Benne | June 4, 2014 |
| Z-1844-2014 | Class II | Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provi | June 3, 2014 |
| Z-1577-2014 | Class II | Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board co | April 18, 2014 |
| Z-0821-2014 | Class II | Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The inten | January 25, 2013 |
| Z-0822-2014 | Class II | Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 | January 25, 2013 |
| Z-2301-2012 | Class II | DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA | August 1, 2012 |
| Z-2174-2012 | Class I | Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN | July 18, 2012 |