Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-2203-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Pressure Monitoring Set, C-PMS, G02838

Product Classification:

Class II

Date Initiated: April 30, 2020

Date Posted: June 10, 2020

Recall Number: Z-2203-2020

Event ID: 85605

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.

Status: Terminated

Product Quantity: 6792

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

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

Voluntary or Mandated:

Voluntary: Firm initiated