Carefusion 2200 Inc recalls Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray

Recall date

May 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2650-2020

FDA classification

Class II

Brand / firm

Carefusion 2200 Inc

Sold / distributed

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, 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 Customer listed, including Federal distribution, u…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray