🔍 RecallPedia

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

Class I - Dangerous
🏥 Medical Devices Recalled: February 1, 2017 Cook Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 10/2/2018; 6276169 CFM-200 10/12/2015 10/12/2018; 6278920 CFM-200 10/12/2015 10/12/2018; 6311713 CFM-200 10/23/2015 10/23/2018; 6332089 CFM-200 10/29/2015 10/29/2018; 6360092 CFM-200 11/6/2015 11/6/2018; NS5226487 CFM-200 8/20/2014 8/20/2017; NS5514147 CFM-200 12/12/2014 12/12/2017; NS5658130 CFM-200 2/16/2015 2/16/2018; NS5712801 CFM-200 3/11/2015 3/11/2018; NS5759898 CFM-200 3/30/2015 3/30/2018; NS5864632 CFM-200 5/6/2015 5/6/2018; NS5871863 CFM-200 5/11/2015 5/11/2018; NS5945483 CFM-200 6/9/2015 6/9/2018; NS6091885 CFM-200 8/4/2015 8/4/2018; NS6126832 CFM-200 8/17/2015 8/17/2018; NS6147094 CFM-200 8/24/2015 8/24/2018; NS6360093 CFM-200 11/6/2015 11/6/2018.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Cook Inc.
Reason for Recall:
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

Product Codes/Lot Numbers:

Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 10/2/2018; 6276169 CFM-200 10/12/2015 10/12/2018; 6278920 CFM-200 10/12/2015 10/12/2018; 6311713 CFM-200 10/23/2015 10/23/2018; 6332089 CFM-200 10/29/2015 10/29/2018; 6360092 CFM-200 11/6/2015 11/6/2018; NS5226487 CFM-200 8/20/2014 8/20/2017; NS5514147 CFM-200 12/12/2014 12/12/2017; NS5658130 CFM-200 2/16/2015 2/16/2018; NS5712801 CFM-200 3/11/2015 3/11/2018; NS5759898 CFM-200 3/30/2015 3/30/2018; NS5864632 CFM-200 5/6/2015 5/6/2018; NS5871863 CFM-200 5/11/2015 5/11/2018; NS5945483 CFM-200 6/9/2015 6/9/2018; NS6091885 CFM-200 8/4/2015 8/4/2018; NS6126832 CFM-200 8/17/2015 8/17/2018; NS6147094 CFM-200 8/24/2015 8/24/2018; NS6360093 CFM-200 11/6/2015 11/6/2018.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1389-2017

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