Device product
Pressure Monitoring Set, C-PMS, G02838
Z-2203-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 85605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6792
- Official record key
device-enforcement:Z-2203-2020
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.