Device recall

Z-0119-2008: OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic…

FDA device recall · Class II · Opti Medical Systems Inc

Key facts

Recall number (Z-number) Z-0119-2008
Recall event 44880
Product OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
Product code JGS
Recalling firm Opti Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Dec 13, 2007
510(k) numbers K052027
FEI number 3004102403

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)