Events

Rappel de Device Recall Fresenius Crit Line in a Clip (CLiC)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Fresenius Medical Care Renal Therapies Group, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74241
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2044-2016
  • Date de mise en oeuvre de l'événement
    2016-05-24
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146919
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Accessories, blood circuit, hemodialysis - Product Code KOC
  • Cause
    Use of the blood pressure graph located on the crit-line screen of the 2008t hemodialysis machine may result in a frozen screen, possibly causing the blood pump to stop.
  • Action
    Fresenius Medical Care Renal Therapies Group, LLC issued Recall Letter issued 5/24/16 via certified mail. Clinics actively using the CLiC option have been verbally communicated to stop using the CLiC option at . The other clinics that did not activate the CLiC option have been verbally communicated to not activate the CLiC option at this time. A Software update to all 2008T Hemodialysis machines will be required. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. For technical Inquiries, please contact Technical Services at 1-800-227-2572. Additional medical concerns or questions, please contact the Medical Information and Communication line at 855-616-2309 or website www.fresenius-medinfo.com.

Device

Device Recall Fresenius Crit Line in a Clip (CLiC)
  • Modèle / numéro de série
    S/N: 1C01M140014 1C01M140015 1C01M140020 1C01M140046 1C01M140050 1C01M140055 1C01M140063 1C01M140071 1C01M140075 1C01M140090 1C31M140024 1C31M140025 1C31M140026 1C31M140027 1C31M140028 1C31M140036 1C31M140037 1C31M140058 1C32M140015 1C32M140018 1C32M140019 1C32M140049 1C32M140050 1C32M140051 1C32M140061 1C40M140081 1C40M140086 1C40M140087 1C40M140088 1C41M140001 1C41M140002 1C41M140005 1C41M140085 1C41M140086 1C41M140110 1C41M140117 1C41M140118 1C41M140123 1C41M140124 1C41M140146 1C41M140163 1C41M140180 1C41M140186 1C41M140196 1C41M140215 1C41M140217 1C41M140223 1C41M140236 1C41M140247 1C41M140252 1C41M140257 1C41M140277 1C41M140282 1C41M140285 1C41M140288 1C41M140291 1C41M140306 1C41M140307 1C41M140308 1C41M140312 1C41M140318 1C42M140011 1C42M140012 1C42M140026 1C42M140040 1C42M140044 1C42M140051 1C42M140058 1C42M140061 1C42M140070 1C42M140078 1C42M140081 1C42M140086 1C42M140091 1C42M140120 1C42M140124 1C42M140125 1C42M140127 1C42M140155 1C42M140163 1C42M140198 1C42M140227 1C42M140270 1C43M140006 1C43M140007 1C43M140028 1C43M140042 1C43M140043 1C43M140049 1C43M140050 1C43M140055 1C43M140058 1C43M140099 1C43M140104 1C43M140109 1C43M140122 1C43M140123 1C43M140124 1C43M140126 1C43M140127 1C43M140169 1C43M140170 1C43M140172 1C43M140173 1C43M140175 1C43M140176 1C43M140189 1C43M140197 1C43M140199 1C43M140201 1C43M140202 1C43M140203 1C43M140209 1C43M140230 1C43M140231 1C43M140233 1C43M140234 1C43M140248 1C43M140251 1C43M140252 1C43M140253 1C43M140254 1C43M140258 1C43M140261 1C43M140263 1C43M140265 1C43M140266 1C43M140270 1C43M140278 1C43M140279 1C43M140282 1C43M140286 1C43M140287 1C43M140290 1C43M140294 1C43M140295 1C43M140298 1C43M140300 1C43M140301 1C43M140302 1C43M140306 1C43M140310 1C43M140313 1C43M140314 1C43M140332 1C43M140333 1C43M140360 1C43M140390 1C43M140392 1C43M140409 1C43M140422 1C43M140424 1C44M140001 1C44M140002 1C44M140005 1C44M140011 1C44M140018 1C44M140020 1C44M140027 1C44M140035 1C44M140036 1C44M140047 1C44M140057 1C44M140065 1C44M140066 1C44M140068 1C44M140070 1C44M140071 1C44M140072 1C44M140073 1C44M140077 1C44M140097 1C44M140099 1C44M140100 1C44M140101 1C44M140102 1C44M140103 1C44M140106 1C44M140110 1C44M140111 1C44M140112 1C44M140120 1C44M140130 1C44M140131 1C44M140132 1C44M140133 1C44M140146 1C44M140147 1C44M140149 1C44M140153 1C44M140154 1C44M140155 1C44M140156 1C44M140157 1C44M140158 1C44M140159 1C44M140160 1C44M140164 1C44M140165 1C44M140166 1C44M140167 1C44M140172 1C44M140178 1C44M140179 1C44M140191 1C44M140196 1C44M140202 1C44M140204 1C44M140205 1C44M140206 1C44M140217 1C44M140220 1C44M140221 1C44M140222 1C44M140223 1C44M140229 1C44M140233 1C44M140234 1C44M140237 1C44M140243 1C44M140244 1C44M140245 1C44M140246 1C44M140254 1C44M140255 1C44M140256 1C44M140257 1C44M140274 1C44M140277 1C44M140278 1C44M140279 1C44M140284 1C44M140292 1C44M140304 1C44M140306 1C44M140311 1C44M140325 1C44M140326 1C44M140329 1C44M140338 1C44M140340 1C44M140341 1C44M140342 1C44M140343 1C44M140354 1C44M140356 1C44M140359 1C44M140361 1C44M140366 1C44M140367 1C44M140368 1C44M140371 1C44M140375 1C44M140376 1C44M140378 1C44M140379 1C44M140381 1C44M140382 1C44M140385 1C45M140002 1C45M140003 1C45M140005 1C45M140010 1C45M140014 1C45M140018 1C45M140020 1C45M140021 1C45M140022 1C45M140025 1C45M140026 1C45M140032 1C45M140033 1C45M140035 1C45M140036 1C45M140038 1C45M140039 1C45M140043 1C45M140044 1C45M140045 1C45M140046 1C45M140050 1C45M140052 1C45M140054 1C45M140055 1C45M140058 1C45M140059 1C45M140060 1C45M140061 1C45M140062 1C45M140063 1C45M140064 1C45M140068 1C45M140071 1C45M140073 1C45M140074 1C45M140075 1C45M140076 1C45M140078 1C45M140082 1C45M140083 1C45M140084 1C45M140085 1C45M140086 1C45M140090 1C45M140091 1C45M140092 1C45M140093 1C45M140094 1C45M140105 1C45M140108 1C45M140109 1C45M140110 1C45M140112 1C45M140114 1C45M140115 1C45M140119 1C45M140129 1C45M140130 1C45M140131 1C45M140132 1C45M140133 1C45M140134 1C45M140136 1C45M140143 1C45M140144 1C45M140146 1C45M140153 1C45M140157 1C45M140160 1C45M140161 1C45M140162 1C45M140163 1C45M140164 1C45M140174 1C45M140176 1C45M140185 1C45M140186 1C45M140187 1C45M140188 1C45M140189 1C45M140195 1C45M140196 1C45M140197 1C45M140198 1C45M140200 1C45M140202 1C45M140203 1C45M140207 1C45M140212 1C45M140215 1C45M140217 1C45M140218 1C45M140219 1C45M140225 1C45M140226 1C45M140227 1C45M140228 1C45M140229 1C45M140230 1C45M140231 1C45M140232 1C45M140233 1C45M140234 1C45M140240 1C46M140001 1C46M140002 1C46M140004 1C46M140005 1C46M140006 1C46M140007 1C46M140008 1C46M140009 1C46M140011 1C46M140012 1C46M140013 1C46M140014 1C46M140015 1C46M140016 1C46M140017 1C46M140018 1C46M140019 1C46M140020 1C46M140021 1C46M140022 1C46M140024 1C46M140025 1C46M140026 1C46M140027 1C46M140028 1C46M140029 1C46M140030 1C46M140031 1C46M140032 1C46M140033 1C46M140034 1C46M140035 1C46M140036 1C46M140040 1C46M140041 1C46M140042 1C46M140043 1C46M140044 1C46M140046 1C46M140048 1C46M140049 1C46M140050 1C46M140051 1C46M140052 1C46M140053 1C46M140055 1C46M140056 1C46M140058 1C46M140059 1C46M140060 1C46M140061 1C46M140062 1C46M140063 1C46M140064 1C46M140065 1C46M140066 1C46M140067 1C46M140068 1C46M140069 1C46M140070 1C46M140071 1C46M140072 1C46M140073 1C46M140074 1C46M140075 1C46M140076 1C46M140077 1C46M140078 1C46M140079 1C46M140080 1C46M140081 1C46M140082 1C46M140083 1C46M140084 1C46M140085 1C46M140086 1C46M140087 1C46M140088 1C46M140090 1C46M140091 1C46M140092 1C46M140093 1C46M140094 1C46M140095 1C46M140096 1C46M140097 1C46M140098 1C46M140099 1C46M140100 1C46M140101 1C46M140102 1C46M140105 1C46M140106 1C46M140107 1C46M140108 1C46M140109 1C46M140110 1C46M140111 1C46M140112 1C46M140114 1C46M140115 1C46M140116 1C46M140117 1C46M140118 1C46M140119 1C46M140120 1C46M140121 1C46M140122 1C46M140123 1C46M140124 1C46M140125 1C46M140126 1C46M140127 1C46M140128 1C46M140129 1C46M140130 1C46M140131 1C46M140132 1C46M140133 1C46M140135 1C46M140136 1C46M140137 1C46M140138 1C46M140139 1C46M140140 1C46M140141 1C46M140143 1C46M140144 1C46M140145 1C46M140146 1C46M140147 1C46M140148 1C46M140149 1C46M140151 1C46M140152 1C46M140153 1C46M140154 1C46M140155 1C46M140156 1C46M140157 1C46M140158 1C46M140159 1C46M140160 1C46M140161 1C46M140162 1C46M140163 1C46M140164 1C46M140165 1C46M140166 1C46M140167 1C46M140168 1C46M140169 1C46M140172 1C46M140173 1C46M140174 1C46M140175 1C46M140176 1C46M140177 1C46M140178 1C46M140179 1C46M140180 1C46M140181 1C46M140182 1C46M140183 1C46M140184 1C46M140185 1C46M140186 1C46M140187 1C46M140188 1C46M140189 1C46M140190 1C46M140191 1C46M140192 1C46M140193 1C46M140194 1C46M140195 1C46M140196 1C46M140197 1C46M140198 1C46M140200 1C46M140201 1C46M140202 1C46M140203 1C46M140204 1C46M140205 1C46M140206 1C46M140207 1C46M140208 1C46M140210 1C46M140211 1C46M140212 1C46M140213 1C46M140214 1C46M140215 1C46M140216 1C46M140217 1C46M140218 1C46M140219 1C46M140221 1C46M140222 1C46M140223 1C46M140224 1C46M140225 1C46M140227 1C46M140228 1C46M140229 1C46M140230 1C46M140231 1C46M140232 1C46M140233 1C46M140234 1C46M140236 1C46M140237 1C46M140238 1C46M140239 1C46M140240 1C46M140241 1C46M140243 1C46M140244 1C46M140245 1C46M140246 1C46M140247 1C46M140251 1C46M140252 1C46M140253 1C46M140254 1C46M140255 1C46M140257 1C46M140258 1C46M140260 1C46M140261 1C46M140262 1C46M140263 1C46M140264 1C46M140265 1C46M140266 1C46M140267 1C46M140268 1C46M140269 1C46M140270 1C46M140271 1C46M140277 1C46M140283 1C46M140290 1C46M140291 1C46M140292 1C46M140293 1C46M140294 1C46M140296 1C46M140297 1C46M140299 1C46M140300 1C46M140302 1C46M140303 1C46M140306 1C46M140307 1C46M140309 1C46M140310 1C46M140311 1C46M140312 1C46M140313 1C46M140314 1C46M140315 1C46M140317 1C46M140319 1C46M140328 1C46M140329 1C46M140330 1C46M140331 1C46M140332 1C46M140334 1C46M140336 1C46M140337 1C46M140338 1C46M140339 1C46M140340 1C46M140342 1C46M140343 1C46M140344 1C46M140346 1C46M140347 1C46M140348 1C46M140349 1C46M140350 1C46M140351 1C46M140352 1C46M140353 1C46M140354 1C46M140355 1C46M140356 1C46M140357 1C46M140358 1C46M140359 1C46M140360 1C46M140361 1C46M140362 1C46M140363 1C46M140364 1C46M140365 1C46M140366 1C46M140367 1C47M140002 1C47M140003 1C47M140004 1C47M140005 1C47M140006 1C47M140007 1C47M140008 1C47M140009 1C47M140010 1C47M140011 1C47M140012 1C47M140014 1C47M140015 1C47M140016 1C47M140020 1C47M140022 1C47M140024 1C47M140027 1C47M140028 1C47M140030 1C47M140031 1C47M140032 1C47M140033 1C47M140034 1C47M140038 1C47M140042 1C47M140043 1C47M140044 1C47M140046 1C47M140047 1C47M140048 1C47M140049 1C47M140050 1C47M140051 1C47M140052 1C47M140053 1C47M140054 1C47M140055 1C47M140058 1C47M140066 1C47M140080 1C47M140082 1C47M140087 1C47M140089 1C47M140090 1C47M140091 1C47M140093 1C47M140094 1C47M140095 1C47M140099 1C47M140102 1C47M140103 1C47M140105 1C47M140108 1C47M140122 1C47M140123 1C47M140124 1C47M140125 1C47M140126 1C47M140127 1C47M140128 1C47M140129 1C47M140131 1C47M140133 1C47M140134 1C47M140136 1C47M140141 1C47M140142 1C47M140143 1C47M140144 1C47M140145 1C47M140152 1C47M140153 1C47M140154 1C47M140156 1C47M140157 1C47M140158 1C47M140159 1C47M140160 1C47M140161 1C47M140166 1C47M140169 1C47M140170 1C47M140171 1C47M140172 1C47M140173 1C47M140176 1C47M140178 1C47M140179 1C47M140180 1C47M140181 1C47M140184 1C47M140185 1C47M140186 1C47M140189 1C47M140196 1C47M140202 1C47M140205 1C47M140206 1C47M140209 1C47M140210 1C47M140211 1C47M140213 1C47M140220 1C47M140221 1C47M140223 1C47M140224 1C47M140225 1C47M140227 1C47M140229 1C47M140230 1C47M140232 1C47M140233 1C47M140234 1C47M140235 1C47M140236 1C47M140237 1C47M140238 1C47M140239 1C47M140243 1C48M140003 1C48M140005 1C48M140010 1C48M140011 1C48M140012 1C48M140014 1C48M140019 1C48M140024 1C48M140025 1C48M140027 1C48M140028 1C48M140029 1C48M140030 1C48M140032 1C48M140033 1C48M140034 1C48M140035 1C48M140047 1C48M140050 1C48M140051 1C48M140055 1C48M140056 1C48M140057 1C48M140058 1C48M140059 1C48M140060 1C48M140061 1C48M140074 1C48M140075 1C48M140089 1C48M140090 1C48M140091 1C48M140092 1C48M140093 1C48M140099 1C48M140102 1C48M140109 1C48M140110 1C48M140111 1C48M140112 1C48M140113 1C48M140114 1C48M140116 1C49M140001 1C49M140006 1C49M140008 1C49M140014 1C49M140022 1C49M140026 1C49M140029 1C49M140032 1C49M140035 1C49M140039 1C49M140041 1C49M140162 1C49M140191 1C49M140195 1C49M140207 1C50M140009 1C50M140010 1C50M140012 1C51M140060 1C51M140067 1C51M140071 1C51M140077 1C51M140079 1C51M140080 1C51M140081 1C51M140088 1C51M140103 1C51M140104 1C51M140105 1C51M140121 1C51M140122 1C51M140132 1C51M140133 1C51M140134 1C51M140141 1C51M140142 1C51M140148 1C51M140149 1C51M140150 1C52M140033 1C52M140038 1C52M140040 1C52M140047 1C52M140107 1C52M140184 1C52M140193 1C52M140201
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed US (nationwide)
  • Description du dispositif
    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 || CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. || Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: || Model: || 190895 2008T GEN 2 BIBAG w/o CDX || 190713 2008T Hemodialysis SYS with CDX || 190858 2008T Hemodialysis System w/o CDX || 190766 2008T Hemodialysis System w/o CDX
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • Adresse du fabricant
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA