Recall Z-1388-2017— Cook Inc.

Name: FDA recall Z-1388-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-01

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2017-02-01, terminated 2018-09-28. It names one FDA 510(k) clearance: K132592. 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.. Reason: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-01
Terminated: 2018-09-28
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SETCook, Inc.·cleared 2014-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

Data sourced from openFDA. This site is unofficial and independent of the FDA.