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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Level 1 Fast Flow Fluid Warmer's with and without air detection Reorder Number: H-1200 115V and 230V
Recall Number B-1052-13
Classification Class II
Code Info Serial Numbers: S10000010 S10000758 S10000897 S101A00083 S103A00018 S103A00019 S103A00020 S103A00025 S103A00027 S103A00028 S103A00029 S103A00035 S103A00037 S103A00039 S103A00041 S103A00047 S103A00050 S103A00051 S103A00052 S103A00053 S103A00055 S103A00056 S103A00057 S103A00058 S103A00060 S103A00061 S103A00062 S103A00063 S103A00064 S103A00065 S103A00066 S103A00068 S103A00069 S103A00070 S103A00071 S103A00072 S103A00074 S103A00077 S103A00078 S103A00079 S103A00080 S103A00081 S103A00082 S103A00084 S103A00085 S103A00086 S103A00087 S103A00088 S103A00089 S103A00090 S103A00091 S103A00092 S103A00093 S103A00094 S103A00095 S103A00097 S103A00098 S103A00099 S103A00100 S103A00102 S103A00103 S103A00104 S103A00105 S103A00106 S103A00107 S103A00112 S103A00117 S103A00118 S103A00119 S103A00129 S103A00130 S103A00131 S103A00132 S103A00133 S103A00134 S103A00135 S103A00136 S103A00137 S103A00138 S103A00139 S103A00140 S103A00141 S103A00142 S103A00143 S103A00144 S103A00145 S103A00146 20050458 S10000851 S103B00044 S103B00093 S103B00106 S103B00116 S103B00118 S103B00121 S103B00123 S103B00130 S103B00133 S103B00134 S103B00135 S103B00136 S103B00137 S103B00138 S103B00139 S103B00140 S103B00141 S103B00142 S103B00143 S103B00144 S103B00147 S103B00148 S103B00149 S103B00150 S103B00153 S103B00155 S103B00156 S103B00163 S103B00164 S103B00165 S103B00166 S103B00167 S103B00168 S103B00169 S103B00170 S103B00171 S103B00172 S103B00173 S103B00174 S103B00175 S103B00176 S103B00177 S103B00178 S103B00179 S103B00180 S103B00181 S103B00182 S103B00183 S103B00184 S103B00185 S103B00186 S103B00187 S103B00188 S103B00189 S103B00190 S103B00191 S103B00192 S103B00193 S103B00194 S103B00195 S103B00196 S103B00197 S103B00198 S103B00199 S103B00200 S103B00201 S103B00202 S103B00203 S103B00204 S103B00205 S103B00206 S103B00207 S103B00208 S103B00209 S103B00210 S103B00211 S103B00212 S103B00213 S103B00214 S103B00215 S103B00216 S103B00217 S103B00218 S103B00219 S103B00220 S103B00221 S103B00222 S103B00223 S103B00225 S103B00226 S103B00227 S103B00228 S103B00229 S103B00230 S103B00231 S103B00232 S103B00233 S103B00234 S103B00235 S103B00236 S103B00237 S103B00238 S103B00239 S103B00240 S103B00241 S103B00242 S103B00243 S103B00244 S103B00245 S103B00246 S103B00247 S103B00248 S103B00249 S103B00250 S103B00251 S103B00252 S103B00253 S103B00254 S103B00255 S103B00256 S103B00257 S103B00258 S103B00259 S103B00260 S103B00261 S103B00262 S103B00263 S103B00264 S103B00265 S103B00266 S103B00267 S103B00268 S103B00270 S103B00271 S103B00272 S103B00273 S103B00274 S103B00275 S103B00276 S103B00277 S103B00278 S103B00279 S103B00280 S103B00281 S103B00282 S103B00283 S103B00284 S103B00286 S103B00287 S103B00288 S103B00289 S103B00290 S103B00291 S103B00292 S103B00293 S103B00294 S103B00295 S103B00296 S103B00297 S103B00298 S103B00299 S103B00300 S103B00301 S103B00302 S103B00303 S103B00304 S103B00305 S103B00306 S103B00307 S103B00308 S103B00309 S103B00310 S103B00311 S103B00312 S103B00313 S103B00314 S103B00315 S103B00316 S103B00317 S103B00318 S103B00319 S103B00320 S103B00321 S103B00322 S103B00323 S103B00324 S103B00325 S103B00326 S103B00327 S103B00328 S103B00329 S103B00330 S103B00331 S103B00332 S103B00333 S103B00334 S103B00335 S103B00336 S103B00337 S103B00338 S103B00339 S103B00340 S103B00341 S103B00342 S103B00343 S103B00346 S103B00347 S103B00348 S103B00349 S103B00350 S103B00351 S103B00352 S103B00353 S103B00354 S103B00355 S103B00356 S103B00357 S103B00358 S103B00359 S103B00360 S103B00361 S103B00362 S103B00364 S103B00365 S103B00366 S103B00367 S103B00368 S103B00369 S103B00370 S103B00371 S103B00372 S103B00373 S103B00374 S103B00375 S103B00376 S103B00377 S103B00378 S103B00379 S103B00381 S103B00382 S103B00383 S103B00385
Product Distributed Qty 331 (223 US, 108 OUS)
Reason For Recall Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed.

Event Detail

Event Id 64211
Product Type Biologics
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Rockland
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Foreign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain