CDI H/S Cuvette — Class III medical device recall Z-1018-2016
Terminated recall by Sorin Group USA, Inc., reported 2016-03-02, distributed nationwide. The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette doe
| Recall number | Z-1018-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2016-01-19 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 6,859 |
| Lot numbers | TE13, TE18, TE20, TE27, TF11, TG01, TG15, TH06, TH20, TH27, TK03, TK17 |
| Model numbers | 020135802, 020204612, 020208807, 020210805, 020211806, 020277801, 020493806, 044000600, 044002300, 044003200, 044003901, 044004102, 044004700, 044006801, 044009000, 044010200, 044013600, 044016900, 044017601, 044018700, 044019901, 044020900, 044022000, 044022001, 044027700 and 101 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1018-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.