Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufactured from 20-Nov2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.
- 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:
- Terumo Cardiovascular Systems Corporation
- Reason for Recall:
- Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Product Codes/Lot Numbers:
Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufactured from 20-Nov2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1458-2017
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