FDA Device recall Z-0851-2019
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 by Cook, citing the products were manufactured with longer than specified sheaths.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0851-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-21 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | CA, CT, GA, MA, NY, PA, VA, WI |
Product
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Reason
The products were manufactured with longer than specified sheaths.
Identifiers
| code_info | lot 8858425 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0851-2019%22
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