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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Medical

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  Class 2 Device Recall Cook Medical see related information
Date Initiated by Firm April 30, 2020
Date Posted June 02, 2020
Recall Status1 Terminated 3 on March 29, 2021
Recall Number Z-2204-2020
Recall Event ID 85605
Product Classification Catheter, percutaneous - Product Code DQY
Product Pressure Monitoring Tray, C-PMSY, G02854
Code Information 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
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical
812-339-2235
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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