Device recall

Z-1534-2018: Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45…

FDA device recall · Class II · Ethicon, Inc.

Key facts

Recall number (Z-number) Z-1534-2018
Recall event 79668
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.
Product code FMF
Recalling firm Ethicon, Inc.
Recall class Class II
Status Terminated
Termination date Apr 30, 2019
510(k) numbers K070575
FEI number 2210968

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)