Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch Numbers: 3000044413 3000049064 3000050885 3000054157 3000058832 3000062461 3000065084
- 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:
- Maquet Cardiovascular, LLC
- Reason for Recall:
- Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
Product Codes/Lot Numbers:
Batch Numbers: 3000044413 3000049064 3000050885 3000054157 3000058832 3000062461 3000065084
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1585-2019
Related Recalls
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Maquet Cardiovascular
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Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
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Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.