FDAFDA · Food and drugs·Recall number Z-0186-2022
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.
Published November 10, 2021 · Recall initiated: September 28, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Affected 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- Domestic 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.
- Lot
- lot 13846597
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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