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Cook Inc. Recall 88787

Description: Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Cook Inc. Recall 88787 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0186-2022
Event ID88787
Event DescriptionFlexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Product TypeDevices
DistributionDomestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA. Foreign distribution to Germany, Finland, Italy, Netherlands, and Switzerland.
Quantity48 (US)
Recall ReasonAffected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Device Classification20211110
Device Code Infolot 13846597
Center Classification Date20211029
Recall Initiation Date20210928
Recalling FirmCook Inc.
Initial Notification Letter
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