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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73126

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

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Event summary

Timeline bucket
January 19, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sorin Group USA, 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

CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.

Z-1018-2016
Recall number
Z-1018-2016
Initiated
January 19, 2016
Classification
Class III
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
6859

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.

Code information

Catalog Number 6922, 1/2 inch -lots TE27, TH06 and TK03 Catalog Number 6923, 3/8 inch - lots TE13, TE18, TG15, TH20 and TK17 b. Model Number(s): 020204612, 020208807, 020210805, 020211806, 020493806, 044002300, 044003200, 044004102, 044004700, 044010200, 044016900, 044017601, 044018700, 044019901, 044027700, 044035101, 075104103, 075104404, 020135802, 088511700, 084103204, 047000500, 046001601, 065255600, 066110500, 075203800, 627265002, 627304502, 084118101, 020277801, 075101900, 627309201, 075104800, 627138002, 627241801, 627305101, 627239301, 044006801, 627347601, 075203501, 627232601, 627123006, 627280901, 088523400, 627282602, 044022001, 627252001, 044020900, 627147304, 627147403, 627153904, 046003400, 627308201, 044013600, 088511801, 084515200, 044009000, 627282001, 044022000, 066109900, 627286901, 075201201, 075202000, 084103204, 088504901, 088508000, 088513300, 088513501, 627133104, 627139306, 627165604, 627166101, 627167301, 627167501, 627167601, 627167701, 627168001, 627168101, 627179903, 627190501, 627190801, 627197802, 627198001, 627198102, 627212201, 627297401, 047002300, 044000600, 627251001, 627254501, 627283501, 627283601, 627321201, 044003901, 088504400, 627198903, 627214003, 044028900, 627231801, 627240802, 627243501, 627243601, 627243701, 627244602, 627244701, 627246002, 627252001, 627256901, 627260701, 627262303, 627266301, 627269502, 627286802, 627286901, 627290001, 627303901, 627304901, 627336301, 627336402, 627343801, 627346601, 627346701, 627349401 Catalog Number 6924, 1/4 inch - lots TE20, TF11, TG01 , TG15, TH 13 and TH27

Distribution pattern

US Nationwide Distribution and Canada.