EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following c
FDA device recall Z-1937-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- Oak Tree International Holdings, LLC, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 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.
- Date initiated
- 2009-05-26
- Date posted
- 2009-09-10
- Date terminated
- 2012-09-27
- Location
- Elyria, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 (K083099) | Eps Bio Technology Corp. | 2009-01-16 |