Company: Dexcom Inc
Date of Enforcement Report: 2/12/2020
Class II
PRODUCT
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 – Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
- Recall Number: Z-0929-2020
REASON
Temperature deviation did not meet release specifications.
RECALLING FIRM/MANUFACTURER
Degania Silicone, Ltd. on 12/2/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2080 units
DISTRIBUTION
US Distribution to IL