Device recall

Z-1317-2008: LifeScan OneTouch Data Management Software Version 1.0, Part Number…

FDA device recall · Class III · Lifescan Inc

Key facts

Recall number (Z-number) Z-1317-2008
Recall event 46398
Product LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
Product code NBW
Recalling firm Lifescan Inc
Recall class Class III
Status Terminated
Termination date Jul 18, 2008
510(k) numbers K984527
FEI number 2939301

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)