Reported May 16, 2018 · Terminated
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
- Lot codes and dates
- a. Part Number 58401-000 - UDI (Serial No.): (01)00840619079499(11)170615(21)1647100134 (1647100134), (01)00840619079499(11)170912(21)1647100137 (1647100137), (01)00840619079499(11)170912(21)1731100224 (1731100224), (01)00840619079499(11)170914(21)17311002301 (731100230), (01)00840619079499(11)170914(21)1731100228 (1731100228), (01)00840619079499(11)170605(21)1647100140 (1647100140), (01)00840619079499(11)170822(21)1647100135 (1647100135), (01)00840619079499(11)170825(21)1726100215 (1726100215), (01)00840619079499(11)170721(21)1726100214 (1726100214), (01)00840619079499(11)170801(21)1718100164 (1718100164), (01)00840619079499(11)170615(21)1647100139 (1647100139), (01)00840619079499(11)170822(21)1647100146 (1647100146), (01)00840619079499(11)170822(21)1647100136 (1647100136), (01)00840619079499(11)170716(21)1711100147 (1711100147), (01)00840619079499(11)170615(21)1647100143 (1647100143), (01)00840619079499(11)170824(21)1726100204 (1726100204), (01)00840619079499(11)170712(21)1718100166 (1718100166), (01)00840619079499(11)170824(21)1726100205 (1726100205), (01)00840619079499(11)170922(21)1731100241 (1731100241), (01)00840619079499(11)170915(21)1731100231 (1731100231), (01)00840619079499(11)170925(21)1731100243 (1731100243), (01)00840619079499(11)170615(21)1647100144 (1647100144), (01)00840619079499(11)170831(21)1726100209 (1726100209), (01)00840619079499(11)170830(21)1726100218 (1726100218), (01)00840619079499(11)170809(21)1726100216 (1726100216), (01)00840619079499(11)170906(21)1726100210 (1726100210), (01)00840619079499(11)170911(21)1731100220 (1731100220), (01)00840619079499(11)170913(21)1731100226 (1731100226), (01)00840619079499(11)170716(21)1711100154 (1711100154), (01)00840619079499(11)170716(21)1711100155 (1711100155), (01)00840619079499(11)170715(21)1711100151 (1711100151), (01)00840619079499(11)170715(21)1711100150 (1711100150), (01)00840619079499(11)170727(21)1718100171 (1718100171), (01)00840619079499(11)170801(21)1718100173 (1718100173), (01)00840619079499(11)170731(21)1718100159 (1718100159), (01)00840619079499(11)170801(21)1726100213 (1726100213), (01)00840619079499(11)170720(21)1711100157 (1711100157), (01)00840619079499(11)160512(21)1629100112 (1629100112), (01)00840619079499(11)170912(21)1731100222 (1731100222), (01)00840619079499(11)160523(21)1629100120 (1629100120), (01)00840619079499(11)170728(21)1718100162 (1718100162), (01)00840619079499(11)170911(21)1731100221 (1731100221), (01)00840619079499(11)170913(21)1731100227 (1731100227), (01)00840619079499(11)170914(21)1731100229 (1731100229), (01)00840619079499(11)170911(21)1731100219 (1731100219), (01)00840619079499(11)170919(21)1731100239 (1731100239), (01)00840619079499(11)170918(21)1731100238 (1731100238), (01)00840619079499(11)170920(21)1731100237 (1731100237), (01)00840619079499(11)170807(21)1647100141 (1647100141), (01)00840619079499(11)160512(21)1629100118 (1629100118), (01)00840619079499(11)160512(21)1629100116 (1629100116), (01)00840619079499(11)170717(21)1711100148 (1711100148), (01)00840619079499(11)170720(21)1711100152 (1711100152), (01)00840619079499(11)170720(21)1711100149 (1711100149), (01)00840619079499(11)170726(21)1718100160 (1718100160), (01)00840619079499(11)170728(21)1718100161 (1718100161), (01)00840619079499(11)170925(21)1731100244 (1731100244), (01)00840619079499(11)170615(21)1647100138 (1647100138), (01)00840619079499(11)170911(21)1718100172 (1718100172), (01)00840619079499(11)170716(21)1718100169 (1718100169), (01)00840619079499(11)160908(21)1629100103 (1629100103), (01)00840619079499(11)160908(21)1629100105 (1629100105), (01)00840619079499(11)160505(21)1629100111 (1629100111), (01)00840619079499(11)160520(21)1629100113 (1629100113), (01)00840619079499(11)160523(21)1629100117 (1629100117), (01)00840619079499(11)160523(21)1629100123 (1629100123), (01)00840619079499(11)160523(21)1629100124 (1629100124), (01)00840619079499(11)170922(21)1731100240 (1731100240), (01)00840619079499(11)160526(21)1629100122 (1629100122), (01)00840619079499(11)160525(21)1629100119 (1629100119); b. Part Number 58403-000 - UDI (Serial No.): (01)00840619079505(11)151126(21)140165 (140165), (01)00840619079505(11)151126(21)140153 (140153), (01)00840619079505(11)170207(21)TSH101367 (TSH101367), (01)00840619079505(11)170308(21)TSH200754 (TSH200754), (01)00840619079505(11)170308(21)TSH200753 (TSH200753), (01)00840619079505(11)151126(21)140146 (140146), (01)00840619079505(11)151126(21)140131 (140131), (01)00840619079505(11)170308(21)140260 (140260), (01)00840619079505(11)170308(21)140228 (140228), (01)00840619079505(11)170207(21)140186 (140186), (01)00840619079505(11)151126(21)140151 (140151), (01)00840619079505(11)151126(21)140133 (140133), (01)00840619079505(11)151126(21)140166 (140166), (01)00840619079505(11)170207(21)140227 (140227), (01)00840619079505(11)151126(21)140126 (140126), (01)00840619079505(11)170308(21)140259 (140259), (01)00840619079505(11)170207(21)140210 (140210), (01)00840619079505(11)170207(21)140191 (140191), (01)00840619079505(11)170308(21)TSH200773 (TSH200773), (01)00840619079505(11)170308(21)TSH200822 (TSH200822), (01)00840619079505(11)170308(21)TSH200748 (TSH200748), (01)00840619079505(11)151126(21)140130140130 (01)00840619079505(11)170207(21)140198 (140198), (01)00840619079505(11)170207(21)TSH101372 (TSH101372), (01)00840619079505(11)170207(21)140207 (140207), (01)00840619079505(11)170207(21)140220 (140220), (01)00840619079505(11)170207(21)TSH101379 (TSH101379), (01)00840619079505(11)170308(21)TSH200814 (TSH200814), (01)00840619079505(11)170207(21)140173 (140173), (01)00840619079505(11)170207(21)140176 (140176), (01)00840619079505(11)170207(21)140178 (140178), (01)00840619079505(11)170207(21)140188 (140188), (01)00840619079505(11)170207(21)140221 (140221), (01)00840619079505(11)170207(21)140223 (140223), (01)00840619079505(11)170308(21)140276 (140276), (01)00840619079505(11)170308(21)140233 (140233), (01)00840619079505(11)170308(21)140277 (140277), (01)00840619079505(11)151126(21)140144 (140144), (01)00840619079505(11)170207(21)TSH101369 (TSH101369), (01)00840619079505(11)151126(21)TSFA01666TSFA01666 (01)00840619079505(11)170207(21)TSH101375 (TSH101375), (01)00840619079505(11)170207(21)TSH101381 (TSH101381), (01)00840619079505(11)170308(21)TSH200815 (TSH200815), (01)00840619079505(11)170308(21)TSH200755 (TSH200755), (01)00840619079505(11)170207(21)TSH101380 (TSH101380), (01)00840619079505(11)170308(21)TSH200818 (TSH200818), (01)00840619079505(11)170308(21)TSH200821 (TSH200821), (01)00840619079505(11)170308(21)TSH200811 (TSH200811), (01)00840619079505(11)151126(21)TSFA01663 (TSFA01663), (01)00840619079505(11)151126(21)TSFA01667 (TSFA01667), (01)00840619079505(11)151126(21)TSFA01658 (TSFA01658), (01)00840619079505(11)170207(21)TSH101354 (TSH101354), (01)00840619079505(11)170207(21)TSH101353 (TSH101353), (01)00840619079505(11)170308(21)TSH200739 (TSH200739), (01)00840619079505(11)170207(21)TSH101386 (TSH101386), (01)00840619079505(11)170207(21)TSH101349 (TSH101349), (01)00840619079505(11)170308(21)TSH200752 (TSH200752), (01)00840619079505(11)151126(21)TSFA01695 (TSFA01695), (01)00840619079505(11)170207(21)TSH101351 (TSH101351), (01)00840619079505(11)170308(21)TSH200742 (TSH200742), (01)00840619079505(11)151126(21)140129 (140129), (01)00840619079505(11)151126(21)140137 (140137), (01)00840619079505(11)151126(21)140155 (140155), (01)00840619079505(11)151126(21)140171 (140171), (01)00840619079505(11)151126(21)140159 (140159), (01)00840619079505(11)151126(21)140147 (140147), (01)00840619079505(11)151126(21)140138 (140138), (01)00840619079505(11)170308(21)TSH200771 (TSH200771), (01)00840619079505(11)151126(21)140172 (140172), (01)00840619079505(11)151126(21)140123 (140123).
- Amount recalled
- 36 devices
Where it was sold
Why it was recalled
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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