Reported Sep 28, 2016 · Terminated
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The…
Sorin Group USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
St¿ckert S5 SystemS5 Heart-lung machineCardiopulmonary bypass heart-lung
- machine console Product UsageThe St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect
- Lot codes and dates
- Item No.: 48-30-00
- Serial No
28E2464028E2465128E2464228E2467428E2465728E2465228E2467128E2467528E2467628E2467828E24670
- Item No 48-40-00 Serial No
28E2464428E2464128E2464828E2466128E2464328E2465028E2467728E2465928E2465828E2467228E2466628E2466028E2466528E2464528E2464628E2466728E2466828E2466928E24679
- Item No 48-50-00 Serial No28E24647, 28E24663, 28E24673, 28E24664 Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656
- Amount recalled
- 5264 Units Worldwide
Where it was sold
Why it was recalled
Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sorin Group USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.