The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1390-2017·Announced 2017-03-08

Cook Inc. Recalls Flexor Radial Access Sets Due to Blood Loss Reports

Cook Inc. is recalling 41,975 Flexor Radial Access Sets because a specific hemostatic 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 describes a risk of harm (blood loss and procedure delay) without reporting any deaths or serious injuries, 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 41,975 units of the Flexor Radial Access Set, a medical device intended to introduce diagnostic and interventional devices in radial artery access procedures. The affected products are packaged in Tyvek-film sterilizable outer pouches and were distributed worldwide, including to the United States, Canada, and various international markets.

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 source text does not report any deaths or serious injuries associated with these devices.

Healthcare facilities and consumers should stop using the affected Flexor Radial Access Sets and contact Cook Inc. for further instructions on how to return or dispose of the products. The recall covers specific lot numbers and catalog identifiers listed in the official FDA record.

The recalled product

Product
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
Manufacturer
Cook Inc.
Category
Medical Device — Vascular Access
Hazard
Affected units
41,975

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 (4)

  • Catalog Identifier: KCFN-4.0(5.0
  • 6.0
  • 7.0)- / -RA-(S)-HC Codes consist of Lot #
  • RPN #

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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