Class 2 Device Recall EASYMax N SelfMonitoring Blood Glucose System

• Date Initiated by Firm: May 26, 2009
• Date Posted: September 10, 2009
• Recall Status: Terminated on September 27, 2012
• Recall Number: Z-1937-2009
• Recall Event ID: 52352
• 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 OH 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: 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 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 = EPS BIO TECHNOLOGY CORP.