FDA Medical Device Recalls (openFDA)
Cook Inc.: Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
- Recall number
- Z-0851-2019
- Recalling firm
- Cook Inc.
- Product
- Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
- Status
- Terminated
- Initiated
- 2018-12-21
- Posted
- not on file
- Terminated
- 2020-04-30
- Reason
- The products were manufactured with longer than specified sheaths.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall letters dated 12/21/18 were sent to customers.
- Quantity
- 24
- Distribution
- The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
- Lot, serial or model codes
- lot 8858425
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28