Date Initiated by Firm |
January 05, 2006 |
Date Posted |
February 25, 2006 |
Recall Status1 |
Terminated 3 on September 05, 2006 |
Recall Number |
Z-0560-06 |
Recall Event ID |
34292 |
510(K)Number |
K041478
|
Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
|
Product |
BD Logic -- Blood Glucose Monitor. |
Code Information |
All units under the following Catalog Number: 322051(48); 322029; 322068; 322069. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact |
David Pieratos 201-847-4548
|
Manufacturer Reason for Recall |
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
|
FDA Determined Cause 2 |
Other |
Action |
Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006 |
Quantity in Commerce |
840,808 units |
Distribution |
The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = BECTON DICKINSON
|