FDA-Device2020-07-29Class II

Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine

Carefusion 2200 Inc
Hazard

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.

Sold states
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, uploaded.
Affected count
N/A
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2654-2020

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