Reported Mar 2, 2016 · Terminated
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack.…
Sorin Group USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack
- Product UsageHeart/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
- Lot codes and dates
Catalog Number 69221/2 inch -lots TE27TH06 and TK03 Catalog Number 69233/8 inch - lots TE13TE18TG15TH20 and TK17 b
- Model Number(s)
128 of 128 codes
020204612020208807020210805020211806020493806044002300044003200044004102044004700044010200044016900044017601044018700044019901044027700044035101075104103075104404020135802088511700084103204047000500046001601065255600066110500075203800627265002627304502084118101020277801075101900627309201075104800627138002627241801627305101627239301044006801627347601075203501627232601627123006627280901088523400627282602044022001627252001044020900627147304627147403627153904046003400627308201044013600088511801084515200044009000627282001044022000066109900
- Amount recalled
- 6859
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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