Recall Z-0993-2026

Cook Incorporated · initiated November 26, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.

Codes / lots: Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL0-HC: Order Number G49101, UDI (01)00827002491014(17)280708(10)16683401, Lot Number 16683401; Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280709(10)16685978, Lot Number 16685978; Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280804(10)NS16724225, Lot Number NS16724225; Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280808(10)NS16733075, Lot Number NS16733075; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280619(10)16652188, Lot Number 16652188; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280620(10)16653824, Lot Number 16653824; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280626(10)16662713, Lot Number 16662713; Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280626(10)16662715, Lot Number 16662715; Reference Part Number…

Reason for recall

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

FDA-determined cause: Process control

Action taken

Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier. The notice explained the issue, risk to health, and requested the identification and return of the affected product. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Details

Recall number
Z-0993-2026
Initiated
November 26, 2025
Posted by FDA
December 23, 2025
Product code
DYB – Introducer, Catheter
Quantity
7952 units
Distribution
Worldwide distribution.
Recalling firm
Cook Incorporated, Bloomington, IN

Official FDA recall record

Other products in the same recall event

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