Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054, 1210700044, 1131300224, 1132800144, 1201300544, 1207400154, 1210700054, 1131300234, 1132800154, 1201300754, 1207400164, 1213800114, 1131300244, 1132800164, 1201300764, 1207400174, 1213800124, 1131900014, 1132800174, 1201300774, 1207400184, 1213800134, 1131900024, 1132800184, 1201300784, 1208300014, 1213800144, 1131900034, 1132800194, 1201300794, 1208300024, 1213800154, 1131900044, 1132800204, 1203200214, 1208300034, 1131900054, 1200500114, 1203200224, 1208300044, 1131900064, 1200500124, 1203200234, 1208300054.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Instruments Div. of Stryker Corporation
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The 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.
Product Codes/Lot Numbers:
5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054, 1210700044, 1131300224, 1132800144, 1201300544, 1207400154, 1210700054, 1131300234, 1132800154, 1201300754, 1207400164, 1213800114, 1131300244, 1132800164, 1201300764, 1207400174, 1213800124, 1131900014, 1132800174, 1201300774, 1207400184, 1213800134, 1131900024, 1132800184, 1201300784, 1208300014, 1213800144, 1131900034, 1132800194, 1201300794, 1208300024, 1213800154, 1131900044, 1132800204, 1203200214, 1208300034, 1131900054, 1200500114, 1203200224, 1208300044, 1131900064, 1200500124, 1203200234, 1208300054.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1878-2013
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