Flexor Check-Flo Introducer — Class II medical device recall Z-0185-2022
Terminated recall by Cook Inc., reported 2021-11-10, distributed in AR, AZ, CT, FL, GA, IL, LA, MA…. Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo
| Recall number | Z-0185-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2021-09-28 |
| Classified | 2021-10-29 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2024-02-28 |
| Distributed | AR, AZ, CT, FL, GA, IL, LA, MA, ME, MN, ND, NJ, NY, OH, PA, TX, WA |
| Countries outside the US | CH, DE, FI, IT, NL |
| Quantity | 48 |
| Lot numbers | 13861362 |
Product
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0185-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.