Convatec Inc.

Product order number: 125333, Lot number: 0G01881

Gastroenterology-Urology Devices

1

No

USA, including IL

ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; || 1 1/4 in., 32mm; || Made in Dominican Republic; || ConvaTec. || Colostomy pouch

Product Code # 416921; Product Lot # 0J00814

Gastroenterology-Urology Devices

1

No

Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX.

Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch || This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.

Numerous lots produced between June 2009 and September 2010.

Anesthesiology Devices

1

No

Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, Israel, Jordan, Lebanon, Libya, Morocco, Saudi Arabia, United Arab Emirates, Russia, Australia, New Zealand, Japan and Vietnam.

Oxygen Masks- Labeling as follows: || MADA, Inc. || Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; || RESPIREX || Aerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. || RESPIREX || Nebulizer Kits w/Aerosol Mask || Adult || 7 ft. (2.1m) Aerosol Tubing || Manufactured for PSS World Medical Inc. || Unomedical, Inc., Hospilak REF 100-E Aerosol Mask Adult || Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; || Unomedical, Inc., Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing || Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult || Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, || Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing || Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing || Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing || Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing || Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush || MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use || MADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use || MADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use || MADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use || Unomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, || MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, || Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, || Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, || Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, || Adult with 7 (2.1m) Oxygen Tubing, || Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, || Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing || Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, || Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, || Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated || Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask || Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask || Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, || Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, || Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing || TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed || Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed || Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eVal

Numerous lots produced between June 2009 and September 2010.

Anesthesiology Devices

1

No

Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, Israel, Jordan, Lebanon, Libya, Morocco, Saudi Arabia, United Arab Emirates, Russia, Australia, New Zealand, Japan and Vietnam.

Face Tent || Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. || Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Manufactured for Unomedical inc. || Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Manufactured for Unomedical inc. || Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing Manufactured for Unomedical inc. || McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E || Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E || Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 || Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 || Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060

There are three (3) affected Products, each with multiple different serial/lot numbers. Each seperate device shipped has it's own serial/lot number.  1) Product Order Number: #446600 (post acute)  Serial numbers:  600200 600201 600202 600203 600204 600205 600206 600208 600209 600210 600214 600217 600221 600222 600225 600228 600230 600233 600257 600263 600266 600277 600280 600286 600288 600296 600301 600302 600312 600333 600338 600342 600343 600351 600352 700386 700394 700401 700403 700404 700447 700450 700455 700456 700457 700460 700467 700470 700473 700476 700478 700479 700480 700481 700482 700485 700488 700491 700492 700493 700498 700501 700507 700509 700515 700516 700530 700536 700543 700546 700554 700564 700565 700568 700569 700571 700572 700574 700575 700576 700586 700587 700594 700596 700597 700606 700607 700608 700612 700613 700615 700621 700622 700625 700634 700635 700638 700639 700641 700649 700651 700655 700659 700665 700683 700709 700711 700745 700748 700749 700755 700756 700767 700772 700774 700782 700793 700794 700798 700800 700809 700814 700816 700819 700827 700833 700847 700856 700870 700874 700876 700878 700883 700888 700891 700893 700940 700945 700946 700947 700950 700951 700958 700959 700960 700962 700963 700966 700970 700973 700977 700983 700984 700997 700998 700999 701004 701013 701015 701021 701023 701024 701026 701027 701030 701035 701039 701052 701055 701065 701068 701076 701079 701081 701085 701086 701095 701099 701101 701104 701117 701124 701125 701126 701130 701134 701135 701158 701161 701163 701164 701169 701171 701172 701174 701177 701179 701180 701181 701183 701184 701185 701187 701188 701189 701190 701293 701294 701302 701344 701353 701356 701360 701361 701369 701384 701392 701393 701419 701420 701423 701425 701428 701429 701430 701432 701433 701434 701435 701437 701491 701492 701493 902036 902100 902106 902108 902111 902112 902113 902114 902115 902122 902126 902127 902128 902131 902134 902136 902137 902138 902140 902142 902143 902144 902145 902146 902147 902148 902149 902150 902151 902154 902155 902162 902163 902164 902165 902166 902167 902168 902169 902170 902171 902172 902173 902174 902175 902176 902177 902178 902179 902180 902181 902182 902183 902184 902185 902187 902188 902190 902191 902192 902193 902194 902195 902196 902197 902205 902216 902219 902223 902225 902227 902228 902229 902231 902232 902233 902235 902249 902254 902257 902258 902268 902270 902271 902277 902281 902282 902284 902299 902300 902301 902303 902307 902309 902311 902313 902314 902315 902316 902318 902320 902321 902322 902323 902324 902326 902327 902328 902329 902330 902331 902332 902333 902334 902335 902336 902337 902338 902339 902340 902341 902342 902343 902344 902345 902346 902347 902348 902349 902350 902351 902352 902353 902354 902355 902356 902357 902358 902359 902360 902361 902362 902363 902364 902365 902366 902367 902368 902370 902371 902372 902373 902374 902432 902456 905933 905987 905989 905990 905993 906003 906009 906015 906016 906017 906024 906025 906026 906027 906028 906040 906041 906051 906055 906057 906058 906059 906060 906061 906062 906063 906064 906065 906066 906067 906074 906075 906076 906077 906078 906079 906083 906084 906085 906086 906087 906088 906089 906090 906091 906092 906094 906095 906096 906097 906098 906099 906100 906101 906102 906103 906104 906105 906106 906107 906108 906110 906113 906122 906126 906130 906131 906133 906136 906140 906143 906149 906150 906155 906161 906163 906178 906180 906206 906207 906211 906212 906215 906217 906233 906316 906343 906346 906349 906350 906351 906361 906362 906365 906385 06J100 06J101 06J108 06J110 06J115 06J124 700762 700795 700815 701137 701153 701348 701363 600321 700597 700949 700919 700624 701001 700666 700985 06J113 701011 700846 701050 701037 600246 701025 700729 700727 700613 902238 700589 600227 700643 700541 600291 700826;  2) Product Order Number: 446610 (acute)   Serial numbers:  600229 600244 600247 600249 600254 600267 600278 600298 600303 600305 600313 600316 600320 600337 600347 600348 600350 700364 700365 700369 700371 700372 700373 700374 700375 700379 700380 700384 700387 700392 700393 700396 700407 700414 700416 700421 700422 700427 700429 700433 700435 700439 700440 700441 700443 700511 700527 700559 700573 700583 700626 700628 700630 700642 700646 700663 700678 700687 700690 700692 700702 700708 700721 700726 700738 700741 700744 700760 700764 700770 700771 700779 700781 700785 700786 700792 700796 700799 700802 700811 700820 700823 700825 700838 700839 700841 700848 700851 700852 700858 700859 700865 700866 700885 700887 700890 700895 700909 700912 700915 700917 700921 700922 700933 700964 700980 700981 700987 701016 701018 701034 701043 701200 701204 701236 701292 701295 701297 701298 701305 701306 701307 701310 701311 701312 701342 701347 701350 701355 701365 701366 701367 701368 701373 701375 701378 701379 701402 701404 701405 701406 701407 701408 701409 701410 701411 701412 701414 701416 701417 701421 701422 701438 701440 701441 701442 701443 701445 701447 701450 701452 701455 701456 701458 701462 701463 701465 701466 701471 701472 701474 701475 701478 701480 701481 701482 701483 701484 701487 701488 701490 902135 902198 902199 902200 902203 902204 902206 902207 902208 902209 902213 902214 902217 902220 902221 902222 902224 902226 902230 902240 902241 902248 902250 902251 902252 902253 902256 902260 902261 902263 902264 902276 902280 902285 902286 902287 902295 902297 902306 902497 902505 902506 902507 902513 902514 902516 902517 902519 902520 902521 902522 902523 902604 902605 902616 902621 902625 902664 902665 902672 902686 902691 902698 902701 902722 902726 902731 902747 902807 902845 902847 902848 902851 902857 902858 902859 902861 902862 902863 902866 902867 902868 902871 902874 902876 902877 902878 902879 903406 904161 904361 904365 904449 904489 904490 904998 904999 905000 905435 905451 905562 905565 905569 905570 905584 905588 06J107 06J119 700542 700904 700961 700972 701439 701448 701451 902245 902246 902291 902325 902503 902613 902684 902699 902734 902846 902850 902852 600258 600265 600287 600294 600310 600315 600328 600334 600339 600344 600353 700357 700359 700373 700382 700390 700400 700406 700413 700415 700417 700419 700423 700426 700430 700431 700432 700486 700539 700561 700562 700620 700644 700662 700679 700699 700701 700718 700720 700725 700732 700733 700735 700739 700740 700769 700776 700778 700807 700821 700822 700828 700835 700836 700849 700855 700861 700884 700892 700911 700920 700923 700935 700936 700937 700971 700974 701033 701056 701071 701078 701082 701083 701175 701313 701314 701315 701316 701317 701318 701319 701320 701321 701322 701323 701324 701325 701326 701327 701328 701329 701330 701331 701332 701333 701334 701335 701336 701337 701339 701372 701397 701401 701418 701426 701449 701453 701454 701457 701459 701460 701461 701462 701463 701464 701465 701468 701469 701479 701485 902210 902211 902212 902236 902237 902239 902242 902243 902244 902247 902250 902272 902275 902293 902298 902305 902317 902496 902498 902502 902525 902603 902606 902607 902608 902612 902619 902622 902626 902627 902630 902631 902632 902633 902636 902638 902640 902641 902642 902643 902644 902660 902666 902667 902668 902669 902670 902727 902729 902849 902853 902854 902855 902856 902861 902864 902865 903219 903328 903406 904130 904572 904988 905014 905452 905453 06J104 06J105 06J106 06J117 06J120:   3) Product Order Number: 446620 (demo unit)  Serial numbers:  700991 700994 700995 700996 701009 701092 701109 701118 701119 701129 701139 701141 701142 701144 701156 701168 701170 701194 701203 701206 701224 701226 701228 701230 701235 701241 701246 701247 701251 701254 701262 701264 701266 701268 701270 701273 701279 701284 701285 701290 701291 701303 701304 701308 701349 701394 701395 701427 701489 902000 902002 902003 902007 902013 902018 902019 902020 902021 902027 902032 902034 902041 902043 902044 902052 902053 902055 902057 902058 902065 902071 902074 902076 902078 902081 902087 902088 902089 902090 902091 902094 902095 902096 905968 905969 905970 905971 905972 906851 906852 906853 906868 906869 906870 906871 906872 906875 906876 906877 906878 906879 906880 906881 906882 906890 906891 906892 906893 906895 906896 906897 906899 906900 906901 906902 906903 906905 906906 906908 906909 906910 906911 906925 906928 906929 906930 906931 906932 906933 906934 906935 906936 906937 906938 906939 906940 906941 906942 906943 906944 906945 906946 906947 906948 906949 906954 906955 906958 906959 906960 906961 906962 906963 906964 906966 906968 906970 906972 906973 906974 906977 906998 907015 902079 701261 902054 701274 701245 902066 902068

General and Plastic Surgery Devices

2

No

Nationwide distribution.

Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy