Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264
- 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:
- Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Product Codes/Lot Numbers:
Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3243-2018
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