Cook recalls Ring Transjugular Intrahepatic Access Sets with specific part numbers due to potential manufacturing defects that could lead to improper sizing and trimming. Affected products may not function correctly during medical procedures.
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.
Cook is recalling certain Ring Transjugular Intrahepatic Access Sets because they may have been made incorrectly, potentially leading to improper sizing and trimming. This could affect their use in medical procedures and requires attention to ensure safety.
The devices may have been cut to the wrong length, not properly trimmed, and not inspected correctly during manufacturing. This could lead to improper sizing and function during medical procedures, potentially causing complications.
Healthcare professionals using the recalled devices for medical procedures are most at risk. Patients undergoing procedures with these devices may be affected if the devices are not functioning correctly.
Check for part numbers RTPS-100 or RTPS-100-10.0. The affected devices were sold with specific order numbers and lot numbers as listed in the recall notice.
Identify the part number and lot number on your device to confirm if it is affected.
The affected part numbers are RTPS-100 and RTPS-100-10.0.
Cook identified that some devices may have been manufactured out of specification, leading to potential issues with sizing and trimming.
Check the part number and lot number on your device against the specific numbers listed in the recall notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0994-2026 — Cook Cook Hello, I own a Cook that is covered by recall Z-0994-2026 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
