The Recall Desk
HighFDA (Devices)·Z-1392-2017·Announced 2017-03-08

Cook Inc. Recalls Check-Flo Introducer Devices Due to Blood Loss Reports

Cook Inc. is recalling 29 Check-Flo Introducer Hausdorf-Lock Atrial devices worldwide due to increased reports of blood loss associated with the hemostatic 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 is classified as FDA Class II, and the source text describes a risk of harm (blood loss and procedure delay) without reporting specific injuries or hospitalizations, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 29 units of the Check-Flo Introducer Hausdorf-Lock Atrial, a medical device intended for the introduction of balloons, catheters, and other diagnostic or interventional devices. The affected devices are packaged in Tyvek-film sterilizable outer pouches and were distributed in the United States, Canada, and various international locations, including specific VA/DOD facilities.

The recall was initiated 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. The source text does not report any specific injuries, hospitalizations, or deaths associated with these devices.

Healthcare providers and facilities should check their inventory for the specific lot numbers and catalog identifiers listed in the official recall notice. If the affected devices are found, they should be removed from use and returned to Cook Inc. according to the instructions provided by the manufacturer.

The recalled product

Product
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
Manufacturer
Cook Inc.
Category
Medical Device — Introducer
Hazard
Affected units
29

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)

  • RPN #
  • Manufacture Date and Expiration Date: 4826254 RCFW-4.0-35-BV 2014/03 3/1/2017
  • 5040369 RCFW-4.0-35-BV 6/1/2014 6/1/2017
  • 5364287 RCFW-4.0-35-BV 10/15/2014 10/15/2017
  • 5379911 RCFW-4.0-35-BV 10/21/2014 10/21/2017
  • 5400933 RCFW-4.0-35-BV 10/29/2014 10/29/2017
  • 5435105 RCFW-4.0-35-BV 11/11/2014 11/11/2017
  • 5462040 RCFW-4.0-35-BV 11/20/2014 11/20/2017
  • 5474624 RCFW-4.0-35-BV 11/25/2014 11/25/2017
  • NS5424653 RCFW-4.0-35-BV 11/6/2014 11/6/2017
  • NS5424654 RCFW-4.0-35-BV 11/6/2014 11/6/2017
  • 5213872 RCFW-5.0-35-BV 8/14/2014 8/14/2017
  • 5273219 RCFW-5.0-35-BV 9/10/2014 9/10/2017
  • 5302128 RCFW-5.0-35-BV 9/23/2014 9/23/2017
  • 5354215 RCFW-5.0-35-BV 10/10/2014 10/10/2017
  • 5400931 RCFW-5.0-35-BV 10/29/2014 10/29/2017
  • 5523548 RCFW-5.0-35-BV 12/17/2014 12/17/2017
  • 5681717 RCFW-5.0-35-BV 2/26/2015 2/26/2018
  • 5690760 RCFW-5.0-35-BV 3/3/2015 3/3/2018
  • 5701193 RCFW-5.0-35-BV 3/6/2015 3/6/2018

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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