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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79814

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 05, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ICU Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1775-2018
Recall number
Z-1775-2018
Initiated
January 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
36 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

Distributed to the states of CA, FL, NC, NE, NY, and WA.