Flexor Check-Flo Introducer — Class I medical device recall Z-0593-2021
Terminated recall by Cook Inc., reported 2020-12-30, distributed nationwide. There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation
| Recall number | Z-0593-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2020-11-24 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2022-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, EG, ES, FI, FR, GR, HK, HU, IE, IT, LT, LV, MA, NL, NO, PL, PT, SA, SE, SI, SK, ZA |
| Quantity | 458 |
| Lot numbers | 13059453, 13059454, 13059455, 13059463, 13126438, 13197461, 13197463, 13207360, 13207367, 13234807, 13279094, 13279103X, 13346108, NS13059462, NS13260029, NS13304443, NS13312714, NS13346096, NS13352471, NS13372477, NS13410219, NS13426314 |
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Reason for recall
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
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-0593-2021. 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.