The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0185-2022·Announced 2021-11-10

Flexor Check-Flo Introducer recalled for misplaced radiopaque marker

Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall involves a manufacturing defect in marker positioning with no reported patient illnesses or injuries. The stated consequence is increased procedural time rather than patient harm, and the defect can be identified and managed during the procedure.

Plain-English summary

Cook Inc. is recalling Flexor Check-Flo Introducer, Introducer Set (RPN KCFW-6.0-35-45-RB, GPN G09908) from affected lot 13861362. The introducer sheath incorporates a hydrophilic-coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Affected introducers may be manufactured with the radiopaque marker band located just below the Check-Flo proximal fitting instead of at the distal tip. This manufacturing defect may not be identified until the device is placed in a patient and viewed under fluoroscopy, leading to increased procedural time.

Approximately 48 units were distributed domestically to Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maine, Minnesota, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Texas, and Washington. Additional units were distributed internationally to Germany, Finland, Italy, the Netherlands, and Switzerland.

Healthcare facilities using this device lot should discontinue use and contact Cook Inc. for return and replacement instructions.

The recalled product

Product
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Manufacturer
Cook Inc.
Category
Medical Device — Vascular Access Device
Hazard
Affected units
48

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 (1)

  • lot 13861362

Distribution

Distributed in 17 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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