Date Initiated by Firm |
November 23, 2011 |
Date Posted |
January 11, 2012 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number |
Z-0506-2012 |
Recall Event ID |
60581 |
510(K)Number |
K041516
|
Product Classification |
digital thermometer - Product Code FLL
|
Product |
Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226 |
Code Information |
Model WIC551226, UPC 31191708790, all lots. |
Recalling Firm/ Manufacturer |
Walgreen Company 200 Wilmot Rd # 3395 Deerfield IL 60015-4620
|
For Additional Information Contact |
Walgreens Product Quality Dept. 847-315-2755
|
Manufacturer Reason for Recall |
The thermometers have been reported to have inaccurate readings
|
FDA Determined Cause 2 |
Labeling design |
Action |
On November 23, 2011, Walgreens issued a recall notice electronically to their stores, instructing them to pull and quarantine the Thermometers and placing a Stop Scan on the products in the computer cash register system on the same date. Walgreens also removed the thermometer from their internet sales site. |
Quantity in Commerce |
estimated 92,000 units |
Distribution |
Nationwide through Walgreens retail stores and their internet site. |
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 = FLL and Original Applicant = VEGA TECHNOLOGIES, INC.
|