FDA-Device2018-12-26Class II

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

COVIDIEN LLC
Hazard

The product was released into commercial distribution while subject to importation refusal.

Sold states
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Affected count
32,071 units
Manufactured in
15 Hampshire St, Mansfield, MA, United States
Products
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0656-2019

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