Ethicon, Inc. recalls Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fi…

Recall date

March 7, 2018

Source

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

Recall number

Z-1534-2018

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

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.

Why it was recalled

Products labeled for distribution outside the United States may have been distributed to customers in the United States.

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

What was recalled

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.