FDA-Device2018-05-02Class II
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Ethicon, Inc.
Hazard
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Sold states
The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.
Affected count
738 devices (246 boxes of 3)
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2018Don't want to check this manually?
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