Device 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.
Z-1534-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 79668
- Status
- Terminated
- Classification
- Class II
- Quantity
- 738 devices (246 boxes of 3)
- Official record key
device-enforcement:Z-1534-2018
Official wording
Reason: Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Code information: Lot 17-0102
Distribution pattern: 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.
Derived failure modes
-
Unknown
Products labeled for distribution outside the United States may have been distributed to customers in the United States.