Reported Aug 14, 2013 · Terminated
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for…
Stryker Instruments Div. of Stryker Corporation
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: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V)
- Product UsageThe Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery
- Lot codes and dates
- 5450-852-000 (Console 230V)
- with SN
11340001141206800484 12109002741134000124120680049412109002841134000134 120680050412109002941134000144120680051412109003041134000154120680052412118000641134000164120680053412118000741134000174120680054412118000841134000184120870001412118000941134000194120870002412129000141134000204120870003412131001141201700324120870004412131001241201700334120870005412131001341201700344120940016412131001441201700354120940017412131001541201700364120940018412065000141209400194120650002412094002041206500034and 1210900264
- Amount recalled
- 215 units total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali
This product could cause temporary or reversible health problems — stop using it.
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