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U.S. Department of Health and Human Services

Class 2 Device Recall Negative Pressure Wound Therapy Powered Suction Pump

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 Class 2 Device Recall Negative Pressure Wound Therapy Powered Suction Pumpsee related information
Date Initiated by FirmJanuary 29, 2010
Date PostedNovember 03, 2010
Recall Status1 Terminated 3 on November 10, 2010
Recall NumberZ-0310-2011
Recall Event ID 56825
510(K)NumberK091470 
Product Classification negative pressure wound therapy powered suction pump - Product Code OMP
Productsmith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England
Code Information SN beginning with 07 or E07.  UNITS DONATED - 5: E070900832, E071001786, E071102001, E071102072,  E071102288.    UNITS SOLD - 343: 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  UNITS RENTED - 1145: 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E071101885 E071101889 E071101890 E071101891 E071101892 E071101894 E071101895 E071101896 E071101897 E071101900 E071101901 E071101902 E071101903 E071101904 E071101905 E071101907 E071101908 E071101911 E071101912 E071101913 E071101914 E071101916 E071101917 E071101918 E071101921 E071101923 E071101924 E071101925 E071101926 E071101929 E071101931 E071101933 E071101934 E071101935 E071101938 E071101939 E071101940 E071101941 E071101942 E071101943 E071101944 E071101945 E071101947 E071101949 E071101950 E071101951 E071101952 E071101954 E071101956 E071101957 E071101958 E071101959 E071101961 E071101962 E071101963 E071101964 E071101965 E071101966 E071101967 E071101968 E071101969 E071101970 E071101971 E071101972 E071101973 E071101974 E071101975 E071101976 E071101977 E071101978 E071101980 E071101981 E071101982 E071101983 E071101984 E071101985 E071101986 E071101987 E071101988 E071101989 E071101990 E071101991 E071101992 E071101993 E071101994 E071101995 E071101996 E071101997 E071101998 E071101999 E071102000 E071102002 E071102003 E071102004 E071102005 E071102006 E071102007 E071102008 E071102009 E071102010 E071102011 E071102012 E071102014 E071102015 E071102016 E071102017 E071102018 E071102019 E071102020 E071102021 E071102022 E071102023 E071102024 E071102025 E071102026 E071102027 E071102028 E071102029 E071102030 E071102031 E071102032 E071102033 E071102034 E071102035 E071102037 E071102038 E071102039 E071102040 E071102041 E071102042 E071102043 E071102046 E071102047 E071102048 E071102049 E071102050 E071102051 E071102052 E071102053 E071102054 E071102055 E071102056 E071102057 E071102059 E071102060 E071102062 E071102063 E071102065 E071102066 E071102068 E071102069 E071102074 E071102075 E071102076 E071102077 E071102078 E071102079 E071102080 E071102081 E071102082 E071102083 E071102084 E071102085 E071102086 E071102087 E071102088 E071102089 E071102090 E071102091 E071102095 E071102097 E071102098 E071102100 E071102101 E071102102 E071102103 E071102104 E071102105 E071102106 E071102107 E071102108 E071102109 E071102110 E071102111 E071102112 E071102113 E071102114 E071102116 E071102117 E071102118 E071102120 E071102121 E071102122 E071102123 E071102124 E071102125 E071102126 E071102127 E071102128 E071102129 E071102130 E071102132 E071102133 E071102134 E071102135 E071102136 E071102137 E071102138 E071102139 E071102140 E071102141 E071102142 E071102143 E071102144 E071102145 E071102146 E071102148 E071102149 E071102150 E071102151 E071102152 E071102155 E071102157 E071102159 E071102160 E071102163 E071102164 E071102165 E071102166 E071102169 E071102170 E071102172 E071102176 E071102177 E071102178 E071102179 E071102181 E071102183 E071102186 E071102187 E071102188 E071102189 E071102190 E071102191 E071102192 E071102193 E071102197 E071102199 E071102200 E071102201 E071102202 E071102203 E071102204 E071102206 E071102207 E071102208 E071102210 E071102211 E071102213 E071102215 E071102216 E071102218 E071102219 E071102220 E071102221 E071102223 E071102224 E071102225 E071102226 E071102228 E071102229 E071102231 E071102232 E071102233 E071102234 E071102236 E071102237 E071102239 E071102240 E071102241 E071102242 E071102243 E071102245 E071102246 E071102247 E071102248 E071102249 E071102250 E071102251 E071102252 E071102254 E071102255 E071102257 E071102259 E071102260 E071102262 E071102263 E071102265 E071102266 E071102268 E071102269 E071102270 E071102271 E071102273 E071102274 E071102276 E071102277 E071102278 E071102279 E071102280 E071102281 E071102282 E071102283 E071102284 E071102285 E071102287 E071102289 E071102291 E071102292 E071102293 E071102294 E071102295 E071102298 E071102299 E071102300 E071102302 E071102303 E071102305 E071102306 E071102309 E071102310 E071102312 E071102313 E071102314 E071102315 E071102316 E071102318 E071102319 E071102322 E071102325 E071102327 E071102328 E071102329 E071102331 E071102332 E071102333 E071102335 E071102336 E071102337 E071102339 E071102343 E071102345 E071102346 E071102348 E071102350 E071102352 E071102353 E071102354 E071102355 E071102361 E071102362 E071102363 E071102364 E071102365 E071102366 E071102367 E071102368 E071102369 E071102370 E071102371 E071102372 E071102373 E071102374 E071102375 E071102377 E071102378 E071102379 E071102380 E071102381 E071102383 E071102386 E071102387 E071102388 E071102389 E071102396 E071102397 E071102398 E071102399 E071102400 E071102404 E071102408 E071102409 E071102410 E071102411 E071102412 E071102413 E071102414 E071102415 E071102416 E071102417 E071102420 E071102421 E071102422 E071102423 E071102424 E071102425 E071102426 E071102427 E071102428 E071102430 E071102432 E071102433 E071102434 E071102640 E071102643 E071102645 E071102646 E071102648 E071102649 E071102650 E071102651 E071102652 E071102654 E071102655 E071102656 E071102657 E071102659 E071102660 E071102661 E071102664 E071102666 E071102667 E071102668 E071102669 E071102670 E071102671 E071102672 E071102673 E071102674 E071102675 E071102676 E071102677 E071102678 E071102679 E071102680 E071102681 E071102683 E071102684 E071102688 E071102689 E071102690 E071102692 E071102694 E071102696 E071102697 E071102698 E071102699 E071102701 E071102702 E071102706 E071102708 E071102709 E071102712 E071102716 E071102721 E071102723 E071102742 E071102743 E071102749 E071102752 E071102753 E071102756 E071102757 E071102760 E071102761 E071102770 E071102771 E071102774 E071102776 E071102778 E071102779 E071102780 E071102781 E071102782 E071102785 E071102787 E071102788 E071102789 E071102794 E071102798 E071102799 E071102800 E071102801 E071102802 E071102803 E071102807 E071102809.   FOREIGN DISTRIBUTION - 499: E070700152 E070700153 E070700154 E070700155 E070700157 E070700253 E070800290 E070800304 E070800305 E070800307 E070800310 E070800315 E070800316 E070800317 E070800319 E070800320 E070800321 E070800322 E070800324 E070800325 E070800326 E070800327 E070800329 E070800330 E070800331 E070800332 E070800334 E070800335 E070800336 E070800337 E070800338 E070800339 E070800340 E070800341 E070800342 E070800343 E070800344 E070800345 E070800346 E070800347 E070800348 E070800350 E070800352 E070800353 E070800354 E070800357 E070800358 E070800362 E070800365 E070800366 E070800369 E070800370 E070800397 E070800407 E070800412 E070800417 E070800418 E070800419 E070800420 E070800421 E070800422 E070800423 E070800424 E070800425 E070800426 E070800427 E070800428 E070800429 E070800430 E070800431 E070800432 E070800433 E070800435 E070800436 E070800437 E070800438 E070800440 E070800441 E070800442 E070800443 E070800444 E070800445 E070800446 E070800447 E070800448 E070800449 E070800450 E070800451 E070800453 E070800454 E070800455 E070800456 E070800528 E070800529 E070900532 E070900533 E070900536 E070900537 E070900541 E070900545 E070900548 E070900549 E070900550 E070900553 E070900554 E070900557 E070900558 E070900561 E070900562 E070900565 E070900569 E070900570 E070900616 E070900617 E070900618 E070900619 E070900621 E070900622 E070900623 E070900624 E071000926 E071000927 E071000928 E071000929 E071000930 E071000931 E071000932 E071000933 E071000934 E071000935 E071000936 E071000937 E071000938 E071000939 E071000940 E071000941 E071000942 E071000943 E071000944 E071000945 E071000946 E071000947 E071000948 E071000949 E071000950 E071000951 E071000952 E071000953 E071000954 E071000955 E071000956 E071000957 E071000958 E071000959 E071000960 E071000961 E071000962 E071000963 E071000964 E071000965 E071001064 E071001081 E071001283 E071001284 E071001285 E071001286 E071001287 E071001288 E071001289 E071001290 E071001291 E071001292 E071001293 E071001294 E071001295 E071001296 E071001297 E071001298 E071001299 E071001300 E071001301 E071001302 E071001303 E071001304 E071001305 E071001306 E071001307 E071001308 E071001309 E071001310 E071001311 E071001312 E071001313 E071001314 E071001315 E071001316 E071001317 E071001318 E071001319 E071001320 E071001353 E071001417 E071001431 E071001445 E071001447 E071001462 E071001466 E071001529 E071001668 E071001774 E071001776 E071001792 E071001795 E071001804 E071001808 E071001815 E071001817 E071001818 E071001820 E071001821 E071001823 E071001824 E071001828 E071001832 E071001833 E071001835 E071001836 E071001838 E071001839 E071001846 E071001852 E071001856 E071101862 E071101867 E071101868 E071101883 E071101884 E071101886 E071101887 E071101888 E071101893 E071101899 E071101906 E071101909 E071101910 E071101920 E071101927 E071101928 E071101930 E071101932 E071101937 E071102147 E071102153 E071102173 E071102182 E071102194 E071102196 E071102198 E071102205 E071102214 E071102217 E071102256 E071102296 E071102297 E071102301 E071102317 E071102321 E071102326 E071102344 E071102349 E071102376 E071102384 E071102395 E071102405 E071102437 E071102438 E071102439 E071102440 E071102441 E071102442 E071102443 E071102444 E071102445 E071102446 E071102447 E071102448 E071102450 E071102451 E071102452 E071102453 E071102454 E071102455 E071102456 E071102457 E071102458 E071102459 E071102460 E071102461 E071102462 E071102463 E071102464 E071102465 E071102466 E071102467 E071102468 E071102469 E071102470 E071102471 E071102472 E071102473 E071102474 E071102475 E071102476 E071102477 E071102478 E071102479 E071102480 E071102481 E071102482 E071102483 E071102484 E071102485 E071102486 E071102487 E071102488 E071102489 E071102490 E071102491 E071102492 E071102493 E071102494 E071102495 E071102496 E071102497 E071102498 E071102499 E071102500 E071102501 E071102502 E071102503 E071102504 E071102505 E071102506 E071102507 E071102508 E071102509 E071102510 E071102511 E071102512 E071102513 E071102514 E071102515 E071102516 E071102517 E071102518 E071102519 E071102520 E071102521 E071102522 E071102523 E071102524 E071102525 E071102526 E071102527 E071102528 E071102529 E071102530 E071102531 E071102532 E071102533 E071102534 E071102535 E071102536 E071102537 E071102538 E071102539 E071102540 E071102541 E071102542 E071102543 E071102544 E071102545 E071102546 E071102547 E071102548 E071102549 E071102550 E071102551 E071102552 E071102553 E071102554 E071102555 E071102556 E071102557 E071102558 E071102559 E071102560 E071102561 E071102562 E071102563 E071102564 E071102565 E071102566 E071102567 E071102568 E071102569 E071102570 E071102571 E071102572 E071102573 E071102574 E071102575 E071102576 E071102577 E071102578 E071102579 E071102580 E071102581 E071102582 E071102583 E071102584 E071102585 E071102586 E071102587 E071102588 E071102589 E071102590 E071102591 E071102592 E071102593 E071102594 E071102595 E071102596 E071102597 E071102598 E071102599 E071102600 E071102601 E071102602 E071102603 E071102604 E071102605 E071102606 E071102607 E071102608 E071102609 E071102610 E071102611 E071102612 E071102613 E071102614 E071102615 E071102616 E071102617 E071102618 E071102619 E071102620 E071102621 E071102622 E071102623 E071102624 E071102625 E071102626 E071102627 E071102628 E071102629 E071102630 E071102631 E071102632 E071102633 E071102634 E071102635 E071102636 E071102637 E071102638 E071102647 E071102663 E071102686 E071102695 E071102705 E071102711 E071102724 E071102725 E071102726 E071102727 E071102728 E071102729 E071102730 E071102731 E071102732 E071102733 E071102734 E071102735 E071102736 E071102737 E071102738 E071102739 E071102755 E071102762.   DESTROYED - 446: Lot Number 71000889 071000887 071000888 071000897 071000900 071000913 071000920 071000921 071000923 071000970 071000991 071000999 071001000 071001022 E070700085 E070700086 E070700087 E070700088 E070700089 E070700090 E070700091 E070700092 E070700093 E070700095 E070700096 E070700097 E070700101 E070700103 E070700106 E070700107 E070700108 E070700109 E070700111 E070700112 E070700113 E070700114 E070700115 E070700116 E070700117 E070700118 E070700119 E070700121 E070700122 E070700123 E070700124 E070700125 E070700126 E070700127 E070700129 E070700130 E070700132 E070700133 E070700134 E070700137 E070700140 E070700142 E070700143 E070700145 E070700146 E070700147 E070700148 E070700156 E070700158 E070700159 E070700160 E070700161 E070700162 E070700163 E070700164 E070700165 E070700166 E070700167 E070700168 E070700169 E070700170 E070700171 E070700172 E070700173 E070700174 E070700177 E070700178 E070700179 E070700180 E070700182 E070700183 E070700184 E070700185 E070700187 E070700188 E070700190 E070700191 E070700192 E070700193 E070700194 E070700195 E070700196 E070700197 E070700198 E070700200 E070700201 E070700202 E070700203 E070700204 E070700205 E070700206 E070700207 E070700208 E070700209 E070700210 E070700211 E070700212 E070700213 E070700214 E070700215 E070700217 E070700218 E070700221 E070700224 E070700225 E070700226 E070700230 E070700237 E070700241 E070700242 E070700243 E070700244 E070700245 E070700246 E070700247 E070700248 E070700250 E070700251 E070700254 E070700255 E070700259 E070700261 E070700263 E070700265 E070700266 E070700269 E070700311 E070800300 E070800302 E070800311 E070800323 E070800349 E070800351 E070800355 E070800363 E070800376 E070800382 E070800385 E070800390 E070800391 E070800396 E070800401 E070800408 E070800410 E070800462 E070800464 E070800465 E070800468 E070800469 E070800470 E070800471 E070800473 E070800477 E070800478 E070800479 E070800483 E070800484 E070800488 E070800490 E070800492 E070800493 E070800498 E070800501 E070800504 E070800505 E070800506 E070800507 E070800508 E070800509 E070800510 E070800511 E070800512 E070800513 E070800516 E070800517 E070800520 E070800521 E070800523 E070800524 E070800525 E070800527 E070800531 E070900534 E070900535 E070900540 E070900542 E070900543 E070900551 E070900555 E070900560 E070900563 E070900564 E070900566 E070900571 E070900575 E070900577 E070900584 E070900591 E070900592 E070900595 E070900609 E070900614 E070900615 E070900620 E070900625 E070900627 E070900630 E070900634 E070900636 E070900637 E070900638 E070900640 E070900642 E070900644 E070900645 E070900649 E070900650 E070900651 E070900654 E070900655 E070900666 E070900670 E070900671 E070900672 E070900687 E070900689 E070900708 E070900713 E070900717 E070900718 E070900720 E070900728 E070900729 E070900730 E070900731 E070900732 E070900738 E070900739 E070900745 E070900751 E070900778 E070900792 E070900802 E070900805 E070900818 E070900825 E070900829 E070900843 E070900844 E070900846 E071000903 E071000910 E071000919 E071000987 E071000995 E071000998 E071001003 E071001011 E071001012 E071001018 E071001032 E071001033 E071001034 E071001038 E071001045 E071001047 E071001050 E071001051 E071001054 E071001066 E071001076 E071001080 E071001082 E071001086 E071001090 E071001096 E071001105 E071001127 E071001136 E071001142 E071001148 E071001172 E071001179 E071001183 E071001199 E071001228 E071001260 E071001265 E071001327 E071001339 E071001359 E071001404 E071001419 E071001423 E071001426 E071001429 E071001435 E071001442 E071001450 E071001456 E071001460 E071001463 E071001476 E071001480 E071001503 E071001506 E071001507 E071001510 E071001520 E071001524 E071001531 E071001532 E071001533 E071001537 E071001543 E071001549 E071001551 E071001553 E071001558 E071001567 E071001573 E071001577 E071001581 E071001593 E071001596 E071001598 E071001600 E071001605 E071001607 E071001613 E071001616 E071001617 E071001628 E071001648 E071001655 E071001667 E071001672 E071001681 E071001685 E071001688 E071001693 E071001709 E071001711 E071001728 E071001731 E071001732 E071001754 E071001765 E071001798 E071001802 E071001809 E071001840 E071001845 E071101877 E071101898 E071101915 E071101919 E071101922 E071101946 E071101948 E071101955 E071101979 E071102044 E071102045 E071102058 E071102061 E071102064 E071102067 E071102073 E071102092 E071102093 E071102094 E071102115 E071102119 E071102158 E071102162 E071102168 E071102180 E071102184 E071102185 E071102212 E071102222 E071102227 E071102230 E071102235 E071102238 E071102258 E071102261 E071102264 E071102267 E071102275 E071102286 E071102290 E071102307 E071102311 E071102320 E071102323 E071102334 E071102338 E071102340 E071102342 E071102351 E071102356 E071102357 E071102359 E071102360 E071102391 E071102392 E071102393 E071102394 E071102401 E071102402 E071102403 E071102406 E071102418 E071102419 E071102431 E071102436 E071102641 E071102644 E071102685 E071102718 E071102745 E071102763 E071102765 E071102783 E071102791 E071102793 E071102810 E071102812 E071102813 E071102814.   S&N POSSESSION - 279: 071000886 071000919 E070700094 E070700098 E070700099 E070700100 E070700102 E070700104 E070700105 E070700110 E070700120 E070700128 E070700131 E070700135 E070700136 E070700138 E070700139 E070700141 E070700144 E070700149 E070700150 E070700151 E070700175 E070700186 E070700189 E070700199 E070700216 E070700219 E070700220 E070700222 E070700223 E070700228 E070700229 E070700249 E070700252 E070700258 E070700272 E070700275 E070700276 E070800287 E070800308 E070800356 E070800359 E070800360 E070800364 E070800368 E070800371 E070800372 E070800377 E070800380 E070800384 E070800389 E070800395 E070800404 E070800405 E070800406 E070800409 E070800414 E070800415 E070800457 E070800458 E070800480 E070800481 E070800482 E070800489 E070800494 E070800495 E070800496 E070800499 E070800514 E070800518 E070800522 E070800526 E070900538 E070900544 E070900552 E070900556 E070900573 E070900574 E070900579 E070900580 E070900581 E070900585 E070900587 E070900588 E070900589 E070900590 E070900597 E070900600 E070900602 E070900607 E070900608 E070900611 E070900613 E070900629 E070900631 E070900646 E070900652 E070900653 E070900656 E070900684 E070900865 E070900870 E071000907 E071001005 E071001017 E071001021 E071001028 E071001030 E071001031 E071001041 E071001088 E071001091 E071001098 E071001116 E071001121 E071001123 E071001147 E071001159 E071001169 E071001181 E071001187 E071001190 E071001202 E071001218 E071001223 E071001229 E071001233 E071001235 E071001238 E071001239 E071001253 E071001277 E071001347 E071001350 E071001352 E071001383 E071001408 E071001418 E071001425 E071001436 E071001437 E071001438 E071001443 E071001452 E071001453 E071001455 E071001464 E071001479 E071001481 E071001487 E071001491 E071001494 E071001495 E071001502 E071001514 E071001515 E071001521 E071001523 E071001525 E071001530 E071001534 E071001536 E071001538 E071001544 E071001559 E071001564 E071001565 E071001578 E071001601 E071001603 E071001609 E071001615 E071001618 E071001625 E071001635 E071001640 E071001651 E071001666 E071001671 E071001673 E071001680 E071001710 E071001717 E071001722 E071001724 E071001725 E071001746 E071001812 E071001825 E071001834 E071001837 E071001854 E071101953 E071102013 E071102036 E071102070 E071102071 E071102096 E071102099 E071102131 E071102154 E071102156 E071102161 E071102167 E071102171 E071102174 E071102175 E071102195 E071102209 E071102244 E071102253 E071102272 E071102308 E071102324 E071102330 E071102341 E071102347 E071102358 E071102382 E071102385 E071102390 E071102407 E071102435 E071102449 E071102642 E071102653 E071102658 E071102662 E071102665 E071102682 E071102687 E071102691 E071102693 E071102700 E071102703 E071102704 E071102707 E071102710 E071102713 E071102714 E071102715 E071102717 E071102719 E071102722 E071102740 E071102741 E071102744 E071102746 E071102747 E071102748 E071102750 E071102751 E071102754 E071102758 E071102759 E071102764 E071102766 E071102767 E071102768 E071102769 E071102772 E071102773 E071102775 E071102777 E071102784 E071102786 E071102790 E071102792 E071102795 E071102796 E071102797 E071102804 E071102805 E071102806 E071102808 E071102811 E071102815 E071102816         
Recalling Firm/
Manufacturer
Smith & Nephew Inc.
970 Lake Carillon Dr
Ste 110
Saint Petersburg FL 33716-1130
For Additional Information ContactTerry McMahon
727-392-1261
Manufacturer Reason
for Recall
Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin
FDA Determined
Cause 2
Other
ActionSmith & Nephew Inc. FEDEXed overnight an URGENT DEVICE RECALL letter dated January 27, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were to check their inventory and identify any affected product, fill out and return the response form by both mail and fax, and return the affected product with the prepaid Federal Express (FedEx) Ground label provided by Smith & Nephew. For any questions regarding this recall contact the Customer Care Center at (800) 876-1261.
Quantity in Commerce2717 units
DistributionWorldwide Distribution - US including AL, AR, AZ, CA, GA, IL, IN, MA, MD, MD, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and UT and the countries of Australia, UK, South Africa, Canada, Puerto Rico, and New Zealand.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OMP
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