—#181330

Product

Pressure Monitoring Tray, C-PMSY, G02854

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2020-04-30
Posted by FDA: 2020-06-02
Terminated: 2021-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181330. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.