The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1388-2017·Announced 2017-03-08

Cook Inc. Recalls Check-Flo Performer Introducer Sets Due to Blood Loss Risk

Cook Inc. is recalling 854 Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 reports an increase in blood loss without mentioning hospitalizations or fatalities, fitting the criteria for a high-risk product where injury has not yet been reported as severe.

Plain-English summary

Cook Inc. is recalling 854 units of the Check-Flo Performer Introducer Set. These devices are intended for the introduction of balloons, closed and non-tapered end catheters, or other diagnostic and interventional devices. The products were distributed worldwide, including in 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 should stop using the affected devices and contact Cook Inc. for further instructions. The affected lots are identified by specific catalog identifiers and lot numbers listed in the official recall documentation.

The recalled product

Product
Check-Flo Performer Introducer Set, 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 — Interventional Cardiology
Hazard
Affected units
854

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:RCF-4.0(5.0
  • 6.0
  • 7.0
  • 8.0)- / -BV Codes consist of Lot #
  • RPN #
  • Manufacture Date and Expiration Date: 4860671 RCF-4.0-35-J-BV 2014/03 3/1/2017
  • 5018663 RCF-4.0-35-J-BV 6/1/2014 6/1/2017
  • 5152571 RCF-4.0-35-J-BV 8/5/2014 8/5/2017
  • 5219529 RCF-4.0-35-J-BV 9/4/2014 9/4/2017
  • 5475523 RCF-4.0-35-J-BV 12/9/2014 12/9/2017
  • 6125807 RCF-4.0-35-J-BV 9/8/2015 9/8/2018
  • NS5210596 RCF-4.0-35-J-BV 8/27/2014 8/27/2017
  • 4790887 RCF-5.0-35-J-BV 2014/02 2/1/2017
  • 4879368 RCF-5.0-35-J-BV 2014/04 4/1/2017
  • 4995370 RCF-5.0-35-J-BV 5/1/2014 5/1/2017
  • 5018661 RCF-5.0-35-J-BV 6/1/2014 6/1/2017
  • 5105572 RCF-5.0-35-J-BV 7/31/2014 7/31/2017
  • 5191953 RCF-5.0-35-J-BV 8/14/2014 8/14/2017
  • 5230090 RCF-5.0-35-J-BV 9/4/2014 9/4/2017
  • 5335405 RCF-5.0-35-J-BV 10/22/2014 10/22/2017

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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