FDA recall Z-1534-2018

Product

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.

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-03-07

Report date

2018-05-02

Termination date

2019-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2018