Use caution Medical device recall · FDA · Published May 25, 2022

Cook Pressure Monitoring Set Recall: Excess Coating May Cause Blood Clots

Cook recalls pressure monitoring sets with excess coating that could cause blood clots or delayed procedures. Affected units have specific lot numbers and model codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1362-2022Medical device Cook ›

Use caution until it’s fixed

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

Take action

Contact the company

Recalling firmCook Incorporated750 N Daniels Way · Bloomington, IN 47404-9120

✎ GovInfoNow plain-language explainer

Cook is recalling pressure monitoring sets that may have excess coating on the needle, which could lead to blood clots or delayed procedures. This is serious for medical use because it risks complications during critical procedures. Read more at govinfonow.com/recall/60609-cook-pressure-monitoring-set-recall-excess-coating-may-cause-blood.

Source Summary by GovInfoNow · govinfonow.com/recall/60609-cook-pressure-monitoring-set-recall-excess-coating-may-cause-blood · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1362-2022

Cite this page

“Cook Pressure Monitoring Set Recall: Excess Coating May Cause Blood Clots.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60609-cook-pressure-monitoring-set-recall-excess-coating-may-cause-blood. Based on FDA recall #Z-1362-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1362-2022%22&limit=1).

The FDA announced on May 25, 2022, that Cook Incorporated is recalling Pressure Monitoring Sets due to excess coating material that may cause pulmonary embolism or ischemia. Owners should contact the company for a replacement.

How to tell if you have it

Brand: Cook
Product: Pressure Monitoring Set, Single-lumen uncoated central venous catheter
RPN: C-PMS-250
GPN: G02838
UPC: 00827002028388
Units affected: 11,451

The hazard

Context

GovInfoNow's records show Cook Incorporated has 15 other recalls on record since May 5, 2022. Other recent recalls of similar products include Cook Beacon Tip Centimeter Sizing Catheters (April 2, 2026), Cook Medical Spectrum Central Venous Tray Recall (March 5, 2026), and Cook Flexor Check-Flo Introducers and Sets (Nov. 26, 2025). Other recent recalls of similar products include AVID Medical Halyard Kits Recall (April 30, 2026), Abiomed 14 Fr Introducer Kit Recall (May 22, 2026), and Medline Reprocessed Catheters May Cause Inflammation or Infection - Recall (Dec. 22, 2025).

How to tell if you have this one

Check for lot numbers: 9665716, 9679942, 9686540, and other numbers listed in the recall. The product is a Pressure Monitoring Set, Single-lumen uncoated central venous catheter with model RPN C-PMS-250 and GPN G02838.

Brand
Cook
Product
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on the catheter packaging or label to see if it matches the listed numbers.
Contact Cook for Details
Reach out to Cook Incorporated directly for specific instructions on whether to stop using the device or get a replacement.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide. Brazil, Canada,” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 56 days after the firm started it.

May 25, 2022Firm started the recall
Jul 8, 2022FDA classified it Class II
Jul 20, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/60609-cook-pressure-monitoring-set-recall-excess-coating-may-cause-blood">Cook Pressure Monitoring Set Recall: Excess Coating May Cause Blood Clots (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1362-2022 (May 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1362-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.