Recall Z-1599-2021 ยท MDS Sensor, Glucose, Invasive
Medtronic Inc.
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
| Date | Feb 26, 2021 |
| Status | Open, Classified |
| Reason | Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings. |
| Root cause | Under Investigation by firm |
| Action | On February 26, 2021, Medtronic posted the "Urgent Recall Correction" notification to their website. On March 2, 2201, Medtronic provided U.S HCPs, Patients, Distributors and globally affected Clinical trial sites with a copy of the "Urgent Recall Correction" Notification. On March 8, 2021, Medtronic provided OUS patients, HCP and distributions with a copy of the "Urgent Recall Correction" notification Communication was provided to users via: email, fax, and/or mail. In addition to informing affected users about the correction, Medtronic ask consignees to take the following actions: |
| Quantity | 213,110 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.