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.

Recall Insight

This FDA Devices action (record #Z-0186-2022) was formally reported on November 10, 2021, with the manufacturer initiating the action on September 28, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records indicate 48 (US) units are affected.

The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.