Z-2204-2020Class II

Pressure Monitoring Tray, C-PMSY, G02854

Name: Z-2204-2020 Pressure Monitoring Tray, C-PMSY, G02854
Creator: Cook Inc.
Published: 2020-04-30
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-04-30 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Pressure Monitoring Tray, C-PMSY, G02854 on 2020-04-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2204-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Posted: 2020-06-02
Terminated: 2021-03-29
Recalling firm: Cook Incorporated
Product: Pressure Monitoring Tray, C-PMSY, G02854
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 30, 2020, Cook Medical sent an Urgent Medical Device Recall letter to their customers to inform them of the voluntary recall of specific lots of the Pressure Monitoring Set and Pressure Monitoring Tray. The firm instructed customers to examine their inventory immediately to determine if have affected product(s) and quarantine any affected product that remains unused then, cease all distribution and use of the product. Cook Medical requested that customers complete the Acknowledgement and Receipt Form via fax or email within 5 business days of receiving the recall letter, whether or not they had any affected product(s) on hand. Customers were instructed to return the affected product(s) with a copy of the Acknowledgement and Receipt Form to receive a product credit. ***Updated 7/7/20*** The firm sent an updated letter dated July 7, 2020, to inform customers of 14 additional lots of the Pressure Monitoring Tray (GPN G02854) that were inadvertently excluded from the previous letter.
Quantity in commerce: 1899
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2204-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2203-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2204-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code DQY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)