CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
S5 Mast Roller Pump recalled by Sorin Group USA
Sorin Group USA is recalling S5 Mast Roller Pump 85, distributed nationwide in the US. The recall was initiated on 19 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0273-2013
- FDA event ID
- 63383
- Recalling firm
- Sorin Group USA, Arvada, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Sep 2012
- FDA classified
- 8 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 19 Sep 2012 | Recall initiated by company | |
| 8 Nov 2012 | Classified by FDA | +50 days |
| 14 Nov 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Where it was distributed
Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.
Nationwide ArizonaGeorgiaMichiganMississippiNorth CarolinaNew YorkPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is S5 Mast Roller Pump 85 recalled?
Yes. Sorin Group USA recalled S5 Mast Roller Pump 85 on 19 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0273-2013.
Why was it recalled?
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
Which lots are affected?
Serial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784.
Where was it sold?
Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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