Recall Z-0760-2007
Nellcor Puritan Bennett · initiated March 12, 2007
Product
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)
Codes / lots: Serial Numbers: 0619450019 0619450065 0619450072 0619450136 0619450214 0619450387 0619450402 0619460020 0620450072 0620450211 0620450224 0621450055 0621450106 0621450152 0623450106 0624450025 0626450123 0626450144 0626450198 0626450201 0626450229 0626450236 0626450291 0626450344 0626450358 0626450363 0626450394 0626450429 0630450051 0632450125 0632450258 0632450259 0632450315 0632450318 0633450095 0639450015 0639450038 0639450040 0639450052 0639450091 0641450052 0641450061 0641450300 0641450325 0647450012 0647450036 0647450052 0647450169 0647450265 3510060688 3510060784 3510062230 3510062231 3510062250 3510062263 3510062265 3510062272 3510062281 3510062294 3510062295 3510062300 3510062302 3510062304 3510062307 3510062309 3510062311 3510062313 3510062315 3510062318 3510062358 3510062359 3510062360 3510062361 3510062362 3510062363 3510062364 3510062365 3510062366 3510062367 3510062368 3510062369 3510062370 3510062371 3510062372 3510062373 3510062374 3510062375 3510062376 3510062377 3510062378 3510062379 3510062380 3510062381 3510062382 3510062383 3510062385 3510062387 3510062389 3510062390 3510062391 3510062392 3510062393 3510062394 3510062395 3510062396 3510062398 3510062399…
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0760-2007
- Initiated
- March 12, 2007
- Posted by FDA
- April 24, 2007
- Terminated
- December 13, 2012
- Product code
- CBK – Ventilator, Continuous, Facility Use
- 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 AFRICA, SPAIN, TURKEY, UK, & YUGOSLAVIA
- Recalling firm
- Nellcor Puritan Bennett, Pleasanton, CA