Pressure Monitoring Tray, C-PMSY, G02854
- Company
- Cook, Inc.
- Recall Initiated
- April 30, 2020
- Posted
- June 2, 2020
- Terminated
- March 29, 2021
- Recall Number
- Z-2204-2020
- Quantity
- 1899
- Firm Location
- Bloomington, IN
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.
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
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
Root Cause
Process control
Action Taken
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.