RecallRadar

FDA Device recall Z-2204-2020

Pressure Monitoring Tray, C-PMSY, G02854

On 2020-06-10 the FDA classified a Class II recall of Pressure Monitoring Tray, C-PMSY, G02854 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

AgencyFDA Device
Recall numberZ-2204-2020
ClassificationClass II
Statusterminated
Initiated2020-04-30
Published2020-06-10
Last updated2026-09-13 11:55 UTC
CompanyCook
DistributionAK, 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 Tray, C-PMSY, G02854

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: 9402033, 9406111, 9782916, 9789983, 9824026 ***Added 7/7/20*** 9829655, 9850622, 9864806, 9874004, 98…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

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-2204-2020%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.