Check-Flo Performer Introducer — Class II medical device recall Z-0851-2019
Terminated recall by Cook Inc., reported 2019-02-27, distributed in CA, CT, GA, MA, NY, PA, VA, WI. The products were manufactured with longer than specified sheaths.
| Recall number | Z-0851-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2018-12-21 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-04-30 |
| Distributed | CA, CT, GA, MA, NY, PA, VA, WI |
| Quantity | 24 |
| Lot numbers | 8858425 |
| Model numbers | G11571, RCFW-5.0-25-45-RB-CHB |
Product
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Reason for recall
The products were manufactured with longer than specified sheaths.
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-0851-2019. 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.