Device recall

Z-0630-03: OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro…

FDA device recall · Class II · Lifescan Inc

Key facts

Recall number (Z-number) Z-0630-03
Recall event 25381
Product OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
Product code CGA
Recalling firm Lifescan Inc
Recall class Class II
Status Terminated
Termination date Aug 21, 2003
510(k) numbers K970556
FEI number 2939301

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)