Recall Z-1085-05 ยท CBK Ventilator, Continuous, Facility Use
Puritan Bennett
Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP
| Date | Aug 6, 2005 (initiated Apr 20, 2005) |
| Status | Terminated |
| Reason | Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection. |
| Root cause | Other |
| Action | Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly. |
| Quantity | 309 |
| Distribution | USA, Canada and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp., Apr 30, 1998 |