Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Detalles del retiro

Fabricante

Carefusion 211 Inc dba Carefusion

Distribuidor

Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile,China, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep, Dominican Republic, Ecuador, Egypt, Estonia, El Salvador, Finland, France, Germany, Georgia, Greece, Guatemala, Hong Kong, Honduras, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Lybia Jamahiriya, Malaysia, Mexico, Moldova, Morocco, Netherlands, Nepal, Nicaragua, Norway, Oman, Pakistan, Palastine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.

Lote

All Models. Serial Numbers: BCV01807 AEV01754 AFV01269 AFV01692 AFV01694 AFV02330 AFV02338 AFV02339 AFV02349 AFV02350 AFV02515 AGV01817 AGV01818 AGV02135 AGV02189 AGV02296 AGV02306 AGV02344 AHV03372 AJV01001 AJV01242 AJV01292 AJV01297 AJV01300 AJV01301 AJV01701 AJV01702 AJV01703 AJV01716 AJV01718 AJV01732 AJV01733 AJV01746 AJV01748 AJV01749 AJV01819 AJV01820 AJV01824 AJV02086 AJV02088 AJV02089 AJV02090 AJV02091 AJV02093 AJV02097 AJV02099 AJV02208 AJV02306 AJV02311 AJV02320 AJV02321 AJV02322 AJV02323 AJV02324 AJV02325 AJV02326 AJV02327 AJV02328 AJV02329 AJV02330 AJV02331 AJV02332 AJV02333 AJV02334 AJV02335 AJV02337 AJV02338 AJV02341 AJV02342 AJV02343 AJV02344 AJV02345 AJV02346 AJV02347 AJV02349 AJV02350 AJV02351 AJV02352 AJV02353 AJV02354 AJV02355 AJV02356 AJV02357 AJV02358 AJV02359 AJV02965 AKV01257 AKV01272 AKV01303 AKV01304 AKV01305 AKV01306 AKV01307 AKV01308 AKV01309 AKV01310 AKV01311 AKV01312 AKV01313 AKV01323 AKV01324 AKV01325 AKV01326 AKV01327 AKV01328 AKV01329 AKV01333 AKV01334 AKV01336 AKV01337 AKV01338 AKV01339 AKV01345 AKV01347 AKV01348 AKV01350 AKV01351 AKV01355 AKV01358 AKV01362 AKV01920 AKV01944 BAV04617 BAV04618 BAV04619 BAV04620 BAV04621 BAV04623 BAV04624 BAV04625 BAV04626 BAV04629 BAV04799 BAV04800 BAV04801 BAV04802 BAV04803 BBV01262 BBV01263 BBV01264 BBV01265 BBV01266 BBV01267 BBV01268 BBV01269 BBV01270 BBV01271 BBV03347 BBV03353 BBV03354 BBV03356 BBV03357 BBV03361 BBV03366 BBV03555 BBV03627 BBV03628 BBV03629 BBV03630 BBV03631 BBV03632 BBV03633 BBV03634 BBV03635 BBV03636 BBV03637 BBV03638 BBV03639 BBV03640 BBV03641 BBV03642 BBV03643 BBV03644 BBV03645 BBV03646 BBV03647 BBV03648 BBV03649 BBV03652 BBV03653 BBV03654 BBV03655 BBV03656 BBV03657 BBV03658 BBV03659 BBV03710 BBV03711 BBV03712 BCV02567 BCV02590 BCV02598 BCV02604 BCV02607 BCV02608 ACV01035 ACV01054 ACV01058 ACV01061 ACV01092 ACV01099 ACV01500 ACV01501 ACV01503 ACV01504 ACV01505 ACV01510 ACV01511 ACV01512 ACV01515 ACV01519 ACV01525 ACV01526 ACV01529 ACV01537 ACV01538 ACV01539 ACV01540 ACV01542 ACV01545 ACV01547 ACV01552 ACV01554 ACV01556 ACV01557 ACV01560 ACV01563 ACV01565 ACV01566 ACV01571 ACV01575 ACV01577 ACV01580 ACV01582 ACV01583 ACV01584 ACV01592 ACV01593 ACV01594 ACV01601 ACV01602 ACV01603 ACV01604 ACV01605 ACV01606 ACV01607 ACV01608 ACV01610 ACV01611 ACV01616 ACV01620 ACV01623 ACV01625 ACV01629 ACV01630 ACV01632 ACV01633 ACV01634 ACV01635 ACV01637 ACV01638 ACV01639 ACV01640 ACV01646 ACV01647 ACV01649 ACV01650 ACV01653 ACV01654 ACV01655 ACV01658 ACV01668 ACV01679 ACV01681 ACV01682 ACV01691 ACV01692 ACV01696 ACV01704 ACV01708 ACV01709 ACV01711 ACV01716 ACV01717 ACV01719 ACV01720 ACV01726 ACV01739 ACV01744 ACV01751 ACV01752 ACV01757 ACV01759 ADV01001 ADV01006 ADV01025 ADV01031 ADV01037 ADV01044 ADV01048 ADV01050 ADV01052 ADV01055 ADV01057 ADV01059 ADV01061 ADV01186 ADV01192 ADV01207 ADV01226 ADV01241 ADV01251 ADV01257 ADV01259 ADV01263 ADV01265 ADV01282 ADV01283 ADV01289 ADV01292 ADV01293 ADV01297 ADV01299 ADV01304 ADV01318 ADV01319 ADV01326 ADV01327 ADV01328 ADV01329 ADV01331 ADV01336 ADV01338 ADV01342 ADV01349 ADV01351 ADV01354 ADV01369 ADV01372 ADV01390 ADV01414 ADV01422 ADV01435 ADV01436 ADV01437 ADV01451 ADV01501 ADV01505 ADV01513 ADV01516 ADV01522 ADV01530 ADV01531 ADV01534 ADV01535 ADV01537 ADV01538 ADV01539 ADV01540 ADV01544 ADV01546 ADV01552 ADV01553 ADV01554 ADV01555 ADV01556 ADV01557 ADV01559 ADV01563 ADV01564 ADV01565 ADV01568 ADV01570 ADV01571 ADV01572 ADV01573 ADV01575 ADV01578 ADV01581 ADV01583 ADV01585 ADV01587 ADV01589 ADV01592 ADV01595 ADV01597 ADV01603 ADV01615 ADV01616 ADV01620 ADV01622 ADV01635 ADV01637 ADV01639 ADV01640 ADV01641 ADV01645

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States