Reported Jul 20, 2022 · Completed

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Lot codes and dates
  • UDI-DI(01)00827002028388
  • Lot Numbers

    153 of 153 codes

    • 9665716
    • 9679942
    • 9686540
    • 9686549
    • 9689250
    • 9689343
    • 9692548
    • 9692549
    • 9699716
    • 9699717
    • 9705738
    • 9709183
    • 9712150
    • 9712373
    • 9736455
    • 9742510
    • 9746575
    • 9746716
    • 9760404
    • 9760475
    • 9766121
    • 9775119
    • 9780326
    • 9782923
    • 9785433
    • 9792467
    • 9793490
    • 9799632
    • 9799638
    • 9804929
    • 9824019
    • 9826828
    • 9826829
    • 9829654
    • 9830524
    • 9836105
    • 9836209
    • 9871734
    • 9873996
    • 9889391
    • 9892371
    • 9895593
    • 9898132
    • 9898730
    • 9902290
    • 9902927
    • 9910485
    • 9916495
    • 9916503
    • 9924121
    • 9931357
    • 9931541
    • 9938186
    • 9938235
    • 9946241
    • 9952626
    • 9952627
    • 9952726
    • 9954044
    • 9954213
Amount recalled
11,451 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.