FDA Device recall Z-1389-2017

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch

FDA Device
Class II
terminated
Published 2017-03-08

On 2017-03-08 the FDA classified a Class II recall of Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch by Cook, citing devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1389-2017
Classification	Class II
Status	terminated
Initiated	2017-02-01
Published	2017-03-08
Last updated	2026-09-13 11:54 UTC
Company	Cook
Distribution	AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV

Product

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

Reason

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

Identifiers

code_info	Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10… Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 1

code_info

Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10…

Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.