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U.S. Department of Health and Human Services

Class 2 Device Recall EASYMax N SelfMonitoring Blood Glucose System

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 Class 2 Recall
EASYMax N SelfMonitoring Blood Glucose System
see related information
Date Posted September 10, 2009
Recall Status1 Open
Recall Number Z-1937-2009
Recall Event ID 52352
Premarket Notification
510(K) Number
K083099 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.
Code Information Lot Number: 222090401, Serial Numbers: 27U000001 - 27U001700, Strip Expiration Date: 2010/09; Lot Number: 222090902: Serial Numbers: 27U001702 - 27U003401, Strip Expiration Date: 2010/11; Lot Number: 222091101, Serial Numbers: 27U003404 - 27U005903, Strip Expiration Date: 2010/11; Lot Number: 222091103, Serial Numbers: 27U008404 - 27U008503, Strip Expiration Date: 2010/11; Lot Number: 222091102, Serial Numbers: 27U005904 - 27U008242, Strip Expiration Date: 2010/11; Lot Number: 222091103, Serial Numbers: 27U008243 - 27U008430, Strip Expiration Date: 2010/11; and Lot Number: 222091201, Serial Numbers: 27U008504 - 27U010503, Strip Expiration Date: 2010/1.
Recalling Firm/
Manufacturer
Oak Tree International Holdings, LLC, Inc.
1209 Lowell St Ste 10
Elyria, Ohio 44035-4803
For Additional Information Contact Don Chargin
440-822-9101
Manufacturer Reason
for Recall
Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action EPS Technology issued a certified notification letter to the sole distributor/customer: GEMCO, Coconut Creek, FL dated May 26, 2009. The letter describes the potential preset error and its possible consequences to the user/customer. The letter goes on to inform the distributor that EPS Technology Corp. will be sending out letters to all affected user/customers during a direct mailing. If the error is found, the user/customer can either: 1) have the firm's Customer Service Dept. instruct them as to how to fix the unit, or 2) request that a replacement meter be sent to them. For further information, contact EPS Technology Customer Service at 1-866-994-3345.
Quantity in Commerce 5,396 units
Distribution Nationwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VA, WA, WY and HI.
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 = NBW and Original Applicant = EPS BIO TECHNOLOGY CORP.
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