CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Pressure Monitoring Tray, C-pmsy, G02854 recalled by Cook

Cook is recalling Pressure Monitoring Tray, C-pmsy, G02854, distributed in 48 states. The recall was initiated on 30 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 9402033, 9406111, 9782916, 9789983, 9824026 ***Added 7/7/20*** 9829655, 9850622, 9864806, 9874004, 9880413, 9904717, 9910200, 9922162, 9934864, 9954321, 9961179, 10133951, 10142269, 10145133

Quantity recalled1899

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-2204-2020
FDA event ID: 85605
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 30 Apr 2020
FDA classified: 2 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

30 Apr 2020	Recall initiated by company
2 Jun 2020	Classified by FDA	+33 days
10 Jun 2020	Published in enforcement report	+8 days

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

Reason for recall

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

Product as listed by the FDA

Pressure Monitoring Tray, C-PMSY, G02854

Where it was distributed

Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

Which lots are affected?

Lot Numbers: 9402033, 9406111, 9782916, 9789983, 9824026 ***Added 7/7/20*** 9829655, 9850622, 9864806, 9874004, 9880413, 9904717, 9910200, 9922162, 9934864, 9954321, 9961179, 10133951, 10142269, 10145133

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

1 other product · FDA event 85605

This product is part of a recall event; the main page for the event is Pressure Monitoring Set, C-pms, G02838 recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
10 Jun 2020	CLASS II	Pressure Monitoring Set, C-pms, G02838 recalled by Cook	Cook	Other	48 states

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