Agency classClass IIOur severity:High FDA (Devices)·Z-1387-2017·Announced 2017-03-08

Cook Inc. Recalls Check-Flo Performer Introducers Due to Blood Loss Reports

Cook Inc. is recalling 884 Check-Flo Performer Introducers 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. The hazard involves a risk of harm (blood loss and procedure delay) where specific injury counts or hospitalizations are not explicitly reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Cook Inc. is recalling 884 units of the Check-Flo Performer Introducer. These medical devices are intended for the introduction of balloons, closed and non-tapered end catheters, or other diagnostic and interventional devices. The products are packaged in a Tyvek-film sterilizable outer pouch.

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.

The affected units were distributed worldwide, including in the United States and various international locations. The source text does not specify the number of reported illnesses or injuries, nor does it provide specific instructions for consumers on how to return the product.

The recalled product

Product: Check-Flo Performer Introducer, 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: blood-loss
device-malfunction
Affected units: 884

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: RCFW-4.0(5.0
6.0
7.0
8.0)- / -BV Codes consist of Lot #
RPN #
Manufacture Date and Expiration Date: 4826254
RCFW-4.0-35-BV
2014/03
3/1/2017
504036
6/1/2014
6/1/2017
5364287
10/15/2014
10/15/2017
5379911
10/21/2014
10/21/2017
5400933
10/29/2014

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 →

Same manufacturer · Cook Inc.

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FDA (Devices) · 2021-11-24
High
Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24

Same hazard · blood loss