RecallRadar

FDA Device recall Z-2651-2020

Safe-T-Centesis 8 Fr Catheter Drainage Tray

On 2020-07-29 the FDA classified a Class II recall of Safe-T-Centesis 8 Fr Catheter Drainage Tray by Carefusion 2200, citing the Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2651-2020
ClassificationClass II
Statusterminated
Initiated2020-05-28
Published2020-07-29
Last updated2026-09-13 11:55 UTC
CompanyCarefusion 2200
DistributionAL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

Safe-T-Centesis 8 Fr Catheter Drainage Tray

Reason

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Identifiers

code_infoCatalog: PIG1280T UDI: 50885403108400; Batches: 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, 0001345260

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-2651-2020%22

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