S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0272-2013.
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0272-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0272-2013.
Sorin Group USA, Inc.
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Sorin Group Usa, Inc. Recall FAQ
Sorin Group Usa, Inc. is the subject of a medical devices safety report: S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f.... The notice was published on September 19, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 5 units are potentially affected.