Z-0186-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- September 28, 2021
- Termination Date
- February 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 (US)
Product 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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
lot 13846597