| Class 2 Device Recall Cook Medical | |
Date Initiated by Firm | April 30, 2020 |
Date Posted | June 02, 2020 |
Recall Status1 |
Terminated 3 on March 29, 2021 |
Recall Number | Z-2203-2020 |
Recall Event ID |
85605 |
Product Classification |
Catheter, percutaneous - Product Code DQY
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Product | Pressure Monitoring Set, C-PMS, G02838 |
Code Information |
Lot Numbers: 8910219, 8937938, 8951879, 8979177, 8990088, 9007566, 9008052, 9039794, 9351985, 9351986, 9354853, 9359896, 9367663, 9372621, 9380316, 9381545, 9386056, 9386351, 9389523, 9395471, 9395682, 9395683, 9402026, 9403779, 9406107, 9409058, 9412543, 9414585, 9416780, 9486988, 9785433, 9799632, 9799638, 9826828, 9826829, 9829654, 9830524, 9836105, 9836209, 9871734, 9873996, 9880405, 9889391, 9892371, 9898730, 9910485, 9916495, 9916503, 9924121, 9931357, 9931541, 9938235, 9946241, 9952626, 9952627, 9952726, 9954044, 9954213, 9961061, 9969348, 9975178, 10109034, 10111785, 10130377, 10130378, 10134000, 10148417, NS8927417 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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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 | 6792 |
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 |
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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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