Device recall

Z-2118-2015: Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE…

FDA device recall · Class II · Covidien LLC

Key facts

Recall number (Z-number) Z-2118-2015
Recall event 71113
Product Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA2006 NON STERILE SUBASSEMBLY…
Product code FSY
Recalling firm Covidien LLC
Recall class Class II
Status Terminated
Termination date Jun 28, 2017
FEI number 1219930

At a glance

  • None Linked 510(k)s
  • 10–99 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)