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
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0186-2022 |
| Event ID | 88787 |
| Event 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 48 (US) |
| Recall Reason | 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. |
| Device Classification | 20211110 |
| Device Code Info | lot 13846597 |
| Center Classification Date | 20211029 |
| Recall Initiation Date | 20210928 |
| Recalling Firm | Cook Inc. |
| Initial Notification | Letter |
| Similar To |