FDA-Device2025-12-31Class IIPROCESSING DEFECT
Cook Incorporated Flexor Check-Flo Introducers recalled for out-of-specification manufacturing
OTHERNationwide distribution
Check Flexor introducer lot numbers immediately
Cook Medical recalled certain Flexor Check-Flo Introducer and Set models because some units were manufactured out of specification. Affected devices may have been cut to incorrect lengths, not properly trimmed, or not inspected properly. This is a medical device used in vascular procedures.
- Check if your facility has any affected Flexor Check-Flo Introducer lots by matching the part numbers and lot numbers listed in the recall
- Stop using any affected devices immediately
- Contact Cook Medical or your distributor for return or replacement instructions
Hazard
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.
Sold states
Worldwide distribution.
Affected count
7952 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0993-2026More Cook Incorporated recalls
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