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U.S. Department of Health and Human Services

Class 2 Device Recall Walgreens Quick Read Digital Thermometer

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 Class 2 Recall
Walgreens Quick Read Digital Thermometer
see related information
Date Posted January 11, 2012
Recall Status1 Open
Recall Number Z-0506-2012
Recall Event ID 60581
Premarket Notification
510(K) Number
K041516 
Product Classification Thermometer, Electronic, Clinical - 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, Illinois 60015-4620
Consumer Instructions Discard product or return to place of purchase for a full refund or exchange
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FLL and Original Applicant = VEGA TECHNOLOGIES, INC.
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