Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX,
FDA device recall Z-0760-2007 · posted 2007-04-24 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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, LEB
- Date initiated
- 2007-03-12
- Date posted
- 2007-04-24
- Date terminated
- 2012-12-13
- Location
- Pleasanton, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) (K970460) | Puritan Bennett Corp. | 1998-04-30 |