Z-0851-2019Class II

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

Name: Z-0851-2019 Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Creator: Cook Inc.
Published: 2018-12-21
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-12-21 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 on 2018-12-21. FDA classified it as Class II and gives the reason as "The products were manufactured with longer than specified sheaths". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0851-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-02-20
Terminated: 2020-04-30
Recalling firm: Cook Incorporated
Product: Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Product code: DYB Introducer, Catheter
Reason for recall: The products were manufactured with longer than specified sheaths.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall letters dated 12/21/18 were sent to customers.
Quantity in commerce: 24
Distribution: The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Product codes and lots: lot 8858425

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0851-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0851-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-20

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)