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U.S. Department of Health and Human Services

Class 2 Device Recall CADDSolis

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 Class 2 Recall
CADDSolis
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Date Posted February 03, 2011
Recall Status1 Terminated on April 17, 2012
Recall Number Z-1033-2011
Recall Event ID 57650
Premarket Notification
510(K) Number
K072144 
Product Classification Pump, Infusion, Pca - Product Code MEA
Product Smiths Medical, CADD®-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.
Code Information 21-2101-51 Serial Numbers US 1007106 1007174 1007535 1007585 1007662 1008911 1008961 1009011 1010062 1007107 1007179 1007536 1007586 1007666 1008912 1008962 1009012 1010063 1007108 1007185 1007537 1007587 1007668 1008913 1008963 1009013 1010064 1007109 1007186 1007538 1007588 1007670 1008914 1008964 1009014 1010065 1007110 1007188 1007539 1007589 1007671 1008915 1008965 1009015 1010066 1007111 1007190 1007540 1007590 1007689 1008916 1008966 1009016 1010067 1007112 1007191 1007541 1007591 1008865 1008917 1008967 1009017 1010068 1007113 1007192 1007542 1007592 1008866 1008918 1008968 1009018 1010069 1007114 1007193 1007543 1007593 1008867 1008919 1008969 1009019 1010070 1007115 1007194 1007544 1007594 1008868 1008920 1008970 1009020 1010071 1007116 1007195 1007545 1007595 1008870 1008921 1008971 1009021 1010072 1007117 1007196 1007546 1007596 1008871 1008922 1008972 1009022 1010073 1007119 1007197 1007547 1007597 1008872 1008923 1008973 1009023 1010074 1007120 1007198 1007548 1007598 1008873 1008924 1008974 1009024 1010075 1007121 1007199 1007549 1007599 1008874 1008925 1008975 1009025 1010076 1007122 1007200 1007550 1007600 1008875 1008926 1008976 1009026 1010077 1007123 1007201 1007551 1007601 1008876 1008927 1008977 1009027 1010078 1007124 1007202 1007552 1007602 1008877 1008928 1008978 1009028 1010079 1007125 1007503 1007553 1007603 1008878 1008929 1008979 1009029 1010080 1007126 1007504 1007554 1007604 1008879 1008930 1008980 1009030 1010081 1007127 1007505 1007555 1007605 1008880 1008931 1008981 1009031 1010082 1007128 1007506 1007556 1007606 1008881 1008932 1008982 1009032 1010083 1007130 1007507 1007557 1007607 1008882 1008933 1008983 1009033 1010084 1007131 1007508 1007558 1007608 1008883 1008934 1008984 1009034 1010085 1007132 1007509 1007559 1007609 1008884 1008935 1008985 1009035 1010086 1007133 1007510 1007560 1007610 1008885 1008936 1008986 1009036 1010087 1007134 1007511 1007561 1007611 1008886 1008937 1008987 1009037 1010088 1007135 1007512 1007562 1007612 1008887 1008938 1008988 1009038 1010090 1007136 1007513 1007563 1007613 1008888 1008939 1008989 1009039 1010091 1007137 1007514 1007564 1007614 1008889 1008940 1008990 1010040 1010092 1007138 1007515 1007565 1007615 1008890 1008941 1008991 1010041 1010093 1007139 1007516 1007566 1007616 1008891 1008942 1008992 1010042 1010094 1007141 1007517 1007567 1007617 1008892 1008943 1008993 1010043 1010095 1007144 1007518 1007568 1007618 1008893 1008944 1008994 1010044 1010096 1007145 1007519 1007569 1007619 1008894 1008945 1008995 1010045 1010097 1007146 1007520 1007570 1007620 1008895 1008946 1008996 1010046 1010098 1007147 1007521 1007571 1007621 1008897 1008947 1008997 1010047 1010099 1007148 1007522 1007572 1007622 1008898 1008948 1008998 1010049 1010100 1007149 1007523 1007573 1007623 1008899 1008949 1008999 1010050 1010101 1007150 1007524 1007574 1007624 1008900 1008950 1009000 1010051 1010102 1007151 1007525 1007575 1007625 1008901 1008951 1009001 1010052 1010103 1007152 1007526 1007576 1007626 1008902 1008952 1009002 1010053 1010104 1007153 1007527 1007577 1007628 1008903 1008953 1009003 1010054 1010105 1007154 1007528 1007578 1007629 1008904 1008954 1009004 1010055 1010106 1007155 1007529 1007579 1007632 1008905 1008955 1009005 1010056 1010107 1007157 1007530 1007580 1007638 1008906 1008956 1009006 1010057 1010108 1007158 1007531 1007581 1007641 1008907 1008957 1009007 1010058 1010109 1007159 1007532 1007582 1007648 1008908 1008958 1009008 1010059 1010110 1007160 1007533 1007583 1007650 1008909 1008959 1009009 1010060 1010111 1007161 1007534 1007584 1007656 1008910 1008960 1009010 1010061 1010112 1010113 1010166 1010216 1010266 1010316 1010366 1010483 1010535 1010664 1010114 1010167 1010217 1010267 1010317 1010367 1010484 1010536 1010678 1010115 1010168 1010218 1010268 1010318 1010368 1010485 1010537 1010683 1010116 1010169 1010219 1010269 1010319 1010369 1010486 1010538 1010690 1010118 1010170 1010220 1010270 1010320 1010373 1010487 1010539 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1012098 1012148 1012198 1011798 1011848 1011898 1011948 1011999 1012049 1012099 1012149 1012199 1011799 1011849 1011899 1011949 1012000 1012050 1012100 1012150 1012200 1011800 1011850 1011900 1011950 1012001 1012051 1012101 1012151 1012201 1011801 1011851 1011901 1011951 1012002 1012052 1012102 1012152 1012202 1011802 1011852 1011902 1011952 1012003 1012053 1012103 1012153 1012203 1011803 1011853 1011903 1011953 1012004 1012054 1012104 1012154 1012204 1011804 1011854 1011904 1011954 1012005 1012055 1012105 1012155 1012205 1011805 1011855 1011905 1011955 1012006 1012056 1012106 1012156 1012206 1011806 1011856 1011906 1011956 1012007 1012057 1012107 1012157 1012207 1011807 1011857 1011907 1011957 1012008 1012058 1012108 1012158 1012208 1011808 1011858 1011908 1011958 1012009 1012059 1012109 1012159 1012209 1011809 1011859 1011909 1011959 1012010 1012060 1012110 1012160 1012210 1011810 1011860 1011910 1011960 1012011 1012061 1012111 1012161 1012211 1011811 1011861 1011911 1011961 1012012 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1012704 1012378 1012431 1012545 1012598 1012651 1012379 1012432 1012546 1012599 1012652 1012380 1012433 1012547 1012600 1012653 1012381 1012434 1012548 1012601 1012654 1012382 1012435 1012549 1012602 1012655 1012383 1012436 1012550 1012603 1012656 1012384 1012438 1012551 1012604 1012657 1012385 1012439 1012553 1012605 1012658 1012386 1012440 1012554 1012606 1012659 1012387 1012441 1012555 1012607 1012660 1012389 1012442 1012556 1012608 1012661 1012390 1012443 1012557 1012609 1012662 1012391 1012444 1012558 1012610 1012663 1012393 1012445 1012559 1012611 1012664 1012394 1012446 1012561 1012614 1012665 1012395 1012447 1012562 1012616 1012666 1012396 1012448 1012563 1012617 1012668 1012397 1012449 1012564 1012618 1012669 1012398 1012450 1012565 1012619 1012670 1012399 1012451 1012566 1012620 1012671 1012402 1012452 1012567 1012621 1012672 1012403 1012453 1012568 1012622 1012673 1012404 1012454 1012569 1012623 1012674 1012405 1012455 1012570 1012624 1012675 1012406 1012456 1012572 1012625 1012676 1012407 1012457 1012573 1012626 1012677 1012408 1012458 1012574 1012628 1012678 1012409 1012459 1012575 1012629 1012679 1012410 1012460 1012576 1012630 1012680 1012411 1012461 1012577 1012631 1012681 1012412 1012462 1012578 1012632 1012682 1012413 1012463 1012579 1012633 1012683 1012414 1012464 1012580 1012634 1012684 1012415 1012465 1012581 1012635 1012685 1012416 1012466 1012582 1012636 1012686 1012417 1012467 1012583 1012637 1012687 1012418 1012468 1012584 1012638 1012688 SERIAL NUMBER LIST OUS 21-2101-0100-50 1010679 1010670 1011550 1010680 1010671 1011551 1010681 1010672 1011552 1010682 1010673 1011553 1010684 1010674 1011554 1010685 1011515 1011555 1010686 1011516 1011556 1010687 1011517 1011557 1010688 1011518 1011558 1010437 1011519 1011559 1010634 1011520 1011560 1010635 1011521 1011561 1010636 1011522 1011562 1010637 1011523 1011563 1010638 1011524 1010639 1011525 1010640 1011526 1010641 1011527 1010642 1011528 1010643 1011529 1010644 1011530 1010645 1011531 1010647 1011533 1010648 1011534 1010649 1011535 1010650 1011536 1010653 1011537 1010654 1011538 1010655 1011539 1010656 1011540 1010657 1011541 1010658 1011542 1010659 1011543 1010660 1011544 1010662 1011546 1010663 1011547 1010665 1011548 1010666 1011549 21-2101-0200-02 1010432 1010421 1010435 1010436 1010438 1010439 1010440 1010433 1010434 21-2101-0200-03 1010380 1010382 1010375 1010376 1010377 1010378 1010379 1010384 1010385 1010370 1010371 1010372 1010374 21-2101-51 1010048 1007645 1007674 1010089 1007646 1007675 1010117 1007647 1007676 1010125 1007184 1007677 1010145 1007187 1007678 1011257 1007163 1007679 1007182 1007164 1007680 1007169 1007118 1007681 1007170 1007129 1007682 1007171 1007162 1007683 1007172 1007649 1007684 1007173 1007651 1007685 1007175 1007652 1007686 1007176 1007653 1007687 1007631 1007654 1007688 1007633 1007655 1007690 1007642 1007657 1007691 1007165 1007658 1007692 1007166 1007659 1007693 1007167 1007660 1007694 1007168 1007661 1007695 1007177 1007663 1007696 1007178 1007664 1007697 1007180 1007665 1007698 1007181 1007667 1007699 1007183 1007669 1007700 1007643 1007672 1007701 1007644 1007673 1007702 21-2111-0200-02 1012480 1012481 1012482 1012483 1012484 1012485 1012486 1012487 1012488 1012489 1012490 1012491 1012493 1012494 1012495 1012496 1012497 1012498 1012499 1012500 1012501 1012502 1012503 21-2102-51 1007140 1007142 1007143
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Reports of the Cassette Lock mechanism on certain CADD¿-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTICE" dated January 13, 2011 to all consignees/customers. The notice described the product, problem, and action to be taken by the customers. The customers were instructed to have their Pumps undergo a correction which consist of removal and reattachment of the Cassette Latch handle using a new adhesive process. The customers were also instructed to remove the Pump from service if unable to remove cassette (or administration set); to inspect their inventory and identify Pumps; prepare a plan for correction of these Pumps; complete and return the attached CONFIRMATION FORM via fax to 1-800-237-8033 or by email to CADDDSolis_CassetteLock@smiths-medical.com, and if they have distributed the affected product to other persons or facilities, promptly forward this notice to the recipients. If you should have any questions regarding this information, please contact Smith Medical at 1-866-216-8806.
Quantity in Commerce 2903 (2539 US; 364 OUS)
Distribution Worldwide Distribution: USA including states of: AK, AZ, C, CO, DC, FL, GA, ID IL, MA, MI, MN, MO, MT, NE, NH, NM, NY, NC, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WI, and WY; and countries including: Australia, Austria, Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Luxembourg, New Zealand, Qatar, Saudi Arabia, Switzerland and The Netherlands.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEA and Original Applicant = SMITHS MEDICAL MD, INC.
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