510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1937-2009

EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the...

Oak Tree International Holdings, Inc. / initiated 2009-05-26 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Oak Tree International Holdings, LLC, Inc. began a recall of EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1937-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Oak Tree International Holdings, Inc.
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.
Product code
NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
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.