LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with On
FDA device recall Z-0980-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, 'Do you need a snack?' for glucose values from 20 through 59 mg/dL.
- Action taken
- On 6/9/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 584,291 units
- Distribution
- Product was released for distribution to 40,763 consignees worldwide. The firm provided the following distribution information: 124 wholesaler dealers, 224 distributors, 140 retailers and 40,275 consu
- Date initiated
- 2005-06-09
- Date posted
- 2005-07-13
- Date terminated
- 2006-12-21
- Location
- Milpitas, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K021819) | Lifescan, Inc. | 2002-08-23 |