Recall Z-0760-2007 ยท CBK Ventilator, Continuous, Facility Use
Nellcor Puritan Bennett
Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs indicate any combination of alpha characters which specify option and language packs)
| Date | Apr 24, 2007 (initiated Mar 12, 2007) |
| Status | Terminated |
| Reason | In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation. |
| Root cause | Other |
| Action | The correction will extend to the end user. All users will be contacted by mail or through personal contact. In the U.S., all customers were mailed the 'Urgent Device Correction' letter along with a serial number listing of those units which records show were consigned to them beginning on March 12, 2007. The customer communication informs customers of the issue and provides instruction for continued safe use of the device pending the correction. |
| Quantity | 3756 |
| Distribution | Worldwide, including USA, ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, EGYPT, FRANCE, GERMANY, GREECE, GUATEMALA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LEBANON, MEXICO, MOROCCO, NICARAGUA, PANAMA, POLAND, PUERTO RICO, ROMANIA, RUSSIA, SINGAPORE, SOUTH |
| 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 |