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U.S. Department of Health and Human Services

Class 2 Device Recall CADDMS 3 Ambulatory Infusion Pump

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 Class 2 Recall
CADDMS 3 Ambulatory Infusion Pump
see related information
Date Posted August 15, 2008
Recall Status1 Open
Recall Number Z-1621-2008
Recall Event ID 47767
Premarket Notification
510(K) Number
K051568 
Product Classification Pump, Infusion - Product Code FRN
Product CADD-MS ®®3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care patients but can also used in health care facilities.
Code Information USA 440038 440096 440114 440122 440126 440128 440206 440235 440242 440247 440269 440313 440397 440418 440447 440455 440458 440484 440487 440501 440504 440560 440582 440584 440596 440614 440641 440848 440877 442365 442366 442367 442368 442369 442370 442371 442372 442373 442374 442375 442376 442377 442378 442364 442379 442380 442381 442382 442383 442384 442461 442462 442463 442464 442465 442466 442467 442468 442387 442388 442389 442390 442391 442392 442393 442394 442395 442396 442397 442398 442399 442400 442401 442402 442403 442404 442405 442406 442407 442408 442409 442410 442411 442412 442413 442414 442415 442416 442417 442418 442419 442420 442421 442422 442423 442424 442425 442426 442427 442428 442429 442430 442431 442432 442433 442434 442435 442436 442437 442438 442439 442440 442441 442442 442443 442444 442445 442446 442498 442448 441866 441867 441868 441869 441870 441871 441872 441873 441874 441875 441876 441877 441878 441879 441880 441881 441882 441883 441884 441885 441886 441887 441888 441889 441890 441891 441892 441893 441894 441895 441896 441897 441898 441899 441900 441901 441902 441903 441904 441905 441906 441907 441908 441909 441910 441911 441912 441913 441914 441915 441916 441917 441918 441919 441920 441921 441922 441923 441924 441925 441926 441927 441928 441929 441930 441931 441932 441933 441934 441935 441936 441937 441938 441939 441940 441941 441942 441943 441944 441945 441946 441947 441948 441949 441950 441951 441952 441953 441954 441955 441956 441957 441958 441959 441960 441961 441962 441963 441964 441965 441966 441967 441968 441969 441970 441971 441972 441973 441974 441975 441976 441977 441978 441979 441980 441981 441982 441983 441984 441985 441986 441987 441988 441989 441990 441991 441992 441993 441994 441995 441996 441997 441998 441999 442000 442001 442002 442003 442004 442005 442006 442007 442008 442009 442010 442011 442012 442013 442014 442015 442016 442017 442018 442019 442020 442021 442022 442023 442024 442025 442026 442027 442028 442029 442030 442031 442032 442033 442034 442035 442036 442037 442038 442039 442040 442041 442042 442043 442044 442045 442046 442047 442048 442049 442050 442051 442052 442053 442054 442055 442056 442057 442058 442059 442060 442061 442062 442063 442064 442065 442066 442067 442068 442069 442070 442071 442072 442073 442074 442075 442076 442077 442078 442079 442080 442081 442082 442083 442084 442085 442086 442087 442088 442089 442090 442091 442092 442093 442094 442095 442096 442097 442098 442099 442100 442101 442102 442103 442104 442105 442106 442107 442108 442109 442110 442111 442112 442113 442114 442115 442116 442117 442118 442119 442120 442121 442122 442123 442124 442125 442126 442127 442128 442129 442130 442131 442132 442133 442134 442135 442136 442137 442138 442139 442140 442141 442142 442143 442144 442145 442146 442147 442148 442149 442150 442151 442152 442153 442154 442155 442156 442157 442158 442159 442160 442161 442162 442163 442164 442165 442166 442167 442168 442169 442170 442171 442172 442173 442174 442175 442176 442177 442178 442179 442180 442181 442182 442183 442184 442185 442186 442187 442188 442189 442190 442191 442192 442193 442194 442195 442196 442197 442198 442199 442200 442201 442202 442203 442204 442205 442206 442207 442208 442209 442210 442211 442212 442213 442214 442215 442216 442217 442218 442219 442220 442221 442222 442223 442224 442225 442226 442227 442228 442229 442230 442231 442232 442233 442234 442235 442236 442237 442238 442239 442240 442241 442242 442243 442244 442245 442246 442247 442248 442249 442250 442251 442252 442253 442254 442255 442256 442257 442258 442259 442260 442261 442262 442263 442264 442265 442266 442267 442268 442270 442271 442272 442273 442274 442275 442276 442277 442278 442279 442280 442281 442282 442283 442284 442285 442286 442287 442288 442289 442290 442291 442292 442293 442294 442295 442296 442297 442298 442299 442300 442301 442302 442303 442304 442305 442306 442307 442308 442309 442310 442311 442312 442313 442314 442315 442316 442317 442318 442319 442320 442321 442322 442323 442324 442325 442326 442327 442328 442329 442330 442331 442332 442333 442334 442335 442336 442337 442338 442339 442340 442341 442342 442343 442344 442345 442346 442347 442348 442349 442350 442351 442352 442353 442354 442355 442356 442357 442358 442359 442360 442361 442362 442363 442385 441860 441861 441862 441863 441864 441865 442386 442447 OUSA 441857 441858 441859 442269 442492 442493 442494 442495 442496 442497 442482 442483 442484 442485 442486 442487 442488 442489 442490 and 442491.
Recalling Firm/
Manufacturer
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Manufacturer Reason
for Recall
Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS ¿3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Consignees were mailed an Urgent Medical Device Recall letter dated March 7, 2008. (Urgent Field Safety Notice dated March 7, 2008 for International Consignees.) The Urgent letter was addressed to "Risk & Safety Mangers, "Distributors", "Clinicians", "Patients" and "other Customers". The letter contains a Description of the Problem, Results of Investigation, and Advice on Action to be taken by the User which includes contacting Smiths Medical MD, Inc. Customer Service Department to make arrangements for a replacement pump. The letter also requests consignees to return the confirmation form.
Quantity in Commerce 646
Distribution Class II Recall - Worldwide Distribution --- USA including states of PA, TX, KY, FL, MN, GA, HI, NM, MD, and countries of CZ, GB, IT.
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 = FRN and Original Applicant = SMITHS MEDICAL MD, INC.
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