The Recall Desk
HighFDA (Devices)·Z-1389-2017·Announced 2017-03-08

Cook Inc. Recalls Check-Flo Hemostasis Assemblies Due to Blood Loss Reports

Cook Inc. is recalling 1,589 Check-Flo Hemostasis Assemblies because reports indicate increased blood loss associated with the device's valve design.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with reports of blood loss, which is a risk-of-harm product where injury has not yet been explicitly reported as a confirmed adverse event in the source text, fitting the 'High' severity criteria.

Plain-English summary

Cook Inc. is recalling 1,589 units of the Check-Flo Hemostasis Assembly, catalog identifier CFM-200. The affected devices are packaged in Tyvek-film sterilizable outer pouches and were distributed worldwide, including to the United States, Canada, and various international locations.

The recall is being conducted because devices using a specific hemostatic valve design, referred to as a "blue" valve or polyisoprene valve, have an increase in reports of blood loss. This issue could result in a delay in the procedure and blood loss from patients.

Healthcare facilities and consumers who have these devices should stop using them and contact Cook Inc. for instructions on return or replacement. The recall covers specific lot numbers and expiration dates listed in the official FDA record Z-1389-2017.

The recalled product

Product
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,589

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 7 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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