CLASS I Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Femoral Artery Pressure Monitoring Catheter Sets recalled by Cook

Cook is recalling Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are, distributed nationwide in the US. The recall was initiated on 6 Jan 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesRPN/Catalog number: C-NPMS-501J-15 C-NPMSY-501J-15 C-PMS-300-FA C-PMS-300J-FA C-PMS-301-FA C-PMS-301J-FA C-PMS-400-FA C-PMS-401-FA C-PMS-401J-FA C-PMSY-300-FA C-PMSY-300J-FA C-PMSY-400J-FA C-PMSY-401-FA Lots: 6054830 6054831 6072436 6078670 6081720 6083977 NS6054841 NS6054842 NS6075552 NS6082372 NS6082373 NS5833881 NS5881267 NS5881268 NS5892106 NS5892107 NS5892108 NS5914766 NS5922706 NS5928596 NS5932820 NS5932821 NS5967447 NS5967448 NS5967449 NS6014474 NS6014475 NS6014484 NS6014485 NS6042778 NS6042795 NS6042796 NS6050046 NS6063330 NS6063354 NS6075555 NS6100599 NS6100600 NS6108225 NS6124985 NS5888542 NS5928597 NS6028553 NS6042797 NS6090273 NS6090274 NS6100601 NS6130149 5800570 5860387 5891906 5980254 6003160 6062725 6143835 NS5830771 NS5866956 NS5866957 NS5881269 NS6014460 NS6042798 NS6050047 NS6075534 NS6075556 5895598 6129058 6148613 NS5932822 NS5932837 NS5994907 NS6130498 6067782 6139280 NS6042805 NS6130500 6049951 6137353 6139281 6034986 6049957 6067784 NS5833887 NS5866959 NS5881272 NS5881334 NS5881335 NS5919925 NS6047449 NS6054847 NS6054848 NS6072526 NS6072555 NS6082379 NS6090277 NS6105921 NS6124989 NS6130501 NS6148639 NS5866961 NS5866962 NS5892115 NS5922709 NS5932844 NS5974256 NS6031988 NS6031990 NS6042578 NS6050052 NS6050053 NS6031992 NS6031993 NS6130504 NS6137424 NS6054849

Quantity recalled1515

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0801-2016
FDA event ID: 73056
Recalling firm: Cook, Bloomington, IN
Classification: Class I
Status: Terminated
Recall initiated: 6 Jan 2016
FDA classified: 24 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

6 Jan 2016	Recall initiated by company
24 Feb 2016	Classified by FDA	+49 days
2 Mar 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.

Product as listed by the FDA

Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

Where it was distributed

Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

RPN/Catalog number: C-NPMS-501J-15 C-NPMSY-501J-15 C-PMS-300-FA C-PMS-300J-FA C-PMS-301-FA C-PMS-301J-FA C-PMS-400-FA C-PMS-401-FA C-PMS-401J-FA C-PMSY-300-FA C-PMSY-300J-FA C-PMSY-400J-FA C-PMSY-401-FA Lots: 6054830 6054831 6072436 6078670 6081720 6083977 NS6054841 NS6054842 NS6075552 NS6082372 NS6082373 NS5833881 NS5881267 NS5881268 NS5892106 NS5892107 NS5892108 NS5914766 NS5922706 NS5928596 NS5932820 NS5932821 NS5967447 NS5967448 NS5967449 NS6014474 NS6014475 NS6014484 NS6014485 NS6042778 NS6042795 NS6042796 NS6050046 NS6063330 NS6063354 NS6075555 NS6100599 NS6100600 NS6108225 NS6124985 NS5888542 NS5928597 NS6028553 NS6042797 NS6090273 NS6090274 NS6100601 NS6130149 5800570 5860387 5891906 5980254 6003160 6062725 6143835 NS5830771 NS5866956 NS5866957 NS5881269 NS6014460 NS6042798 NS6050047 NS6075534 NS6075556 5895598 6129058 6148613 NS5932822 NS5932837 NS5994907 NS6130498 6067782 6139280 NS6042805 NS6130500 6049951 6137353 6139281 6034986 6049957 6067784 NS5833887 NS5866959 NS5881272 NS5881334 NS5881335 NS5919925 NS6047449 NS6054847 NS6054848 NS6072526 NS6072555 NS6082379 NS6090277 NS6105921 NS6124989 NS6130501 NS6148639 NS5866961 NS5866962 NS5892115 NS5922709 NS5932844 NS5974256 NS6031988 NS6031990 NS6042578 NS6050052 NS6050053 NS6031992 NS6031993 NS6130504 NS6137424 NS6054849

Where was it sold?

Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 73056

This product is part of a recall event; the main page for the event is Single Lumen Pressure Monitoring Sets recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
2 Mar 2016	CLASS I	Single Lumen Pressure Monitoring Sets recalled by Cook	Cook	Other	Nationwide
2 Mar 2016	CLASS I	Single Lumen Central Venous Catheter Sets recalled by Cook	Cook	Other	Nationwide
2 Mar 2016	CLASS I	Radial Artery Pressure Monitoring Catheter Sets recalled by Cook	Cook	Other	Nationwide

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide