FDA Device recall Z-2203-2020

Pressure Monitoring Set, C-PMS, G02838

FDA Device
Class II
terminated
Published 2020-06-10

On 2020-06-10 the FDA classified a Class II recall of Pressure Monitoring Set, C-PMS, G02838 by Cook, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2203-2020
Classification	Class II
Status	terminated
Initiated	2020-04-30
Published	2020-06-10
Last updated	2026-09-13 11:55 UTC
Company	Cook
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV

Product

Pressure Monitoring Set, C-PMS, G02838

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.

Identifiers

code_info	Lot Numbers: 8910219, 8937938, 8951879, 8979177, 8990088, 9007566, 9008052, 9039794, 9351985, 9351986, 9354853, 935989… 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

code_info

Lot Numbers: 8910219, 8937938, 8951879, 8979177, 8990088, 9007566, 9008052, 9039794, 9351985, 9351986, 9354853, 935989…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2203-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.