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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Cook Incorporated Ring Transjugular Intrahepatic Access Sets recalled for manufacturing defects

Cook
OTHERNationwide distributiondevice

Check Cook Ring Transjugular Access Sets for defects

Cook Medical found that certain Ring Transjugular Intrahepatic Access Sets used in liver procedures were manufactured incorrectly. Affected devices may have been cut to the wrong length, trimmed improperly, or not inspected properly before shipment. This involves 15 units distributed worldwide.

  • If your facility has received Cook Ring Transjugular Intrahepatic Access Sets with lot numbers 16705779 or 16659044, do not use them.
  • Contact Cook Medical for instructions on returning or replacing affected devices.
  • Review your inventory against the provided lot numbers and reference part numbers.
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.

Who it affects
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
15 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0994-2026

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