The Recall Desk
HighFDA (Devices)·Z-1391-2017·Announced 2017-03-08

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

Cook Inc. is recalling 778 Micropuncture Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

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 involves a risk of harm (blood loss) without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as severe.

Plain-English summary

Cook Inc. is recalling 778 units of the Micropuncture Check-Flo Performer Introducer Set. These medical 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 to the United States, Canada, and various international locations.

The recall is being issued 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 providers and consumers should stop using the affected devices immediately. The specific lot numbers and catalog identifiers for the recalled units are listed in the official FDA recall notice Z-1391-2017.

The recalled product

Product
Micropuncture 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 Radiology
Hazard
Affected units
778

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: RCFN-4.0(5.0
  • 6.0
  • 7.0)- / -MPIS-NT-BV Codes consist of Lot #
  • RPN #
  • 4734774 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017
  • 4785752 RCFN-4.0-18-MPIS-NT-BV 2014/02 2/1/2017
  • 4941369 RCFN-4.0-18-MPIS-NT-BV 2014/05 5/1/2017
  • 4941371 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017
  • 4941373 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017
  • 4951551 RCFN-4.0-18-MPIS-NT-BV 2014/05 5/1/2017
  • 4951553 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017
  • 5045963 RCFN-4.0-18-MPIS-NT-BV 6/1/2014 6/1/2017
  • 5115985 RCFN-4.0-18-MPIS-NT-BV 7/23/2014 7/23/2017
  • 5115987 RCFN-4.0-18-MPIS-NT-BV 7/30/2014 7/30/2017
  • 5129780 RCFN-4.0-18-MPIS-NT-BV 7/28/2014 7/28/2017
  • 5129782 RCFN-4.0-18-MPIS-NT-BV 7/28/2014 7/28/2017
  • 5201283 RCFN-4.0-18-MPIS-NT-BV 8/28/2014 8/28/2017
  • 5319456 RCFN-4.0-18-MPIS-NT-BV 10/21/2014 10/21/2017
  • 5347620 RCFN-4.0-18-MPIS-NT-BV 10/20/2014 10/20/2017
  • 5347622 RCFN-4.0-18-MPIS-NT-BV 11/6/2014 11/6/2017

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 →

Related recalls

Same manufacturer · Cook Inc.

See all →

Same hazard · blood loss

See all →