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Medtronic Inc. Recall 87476

Description: Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Medtronic Inc. Recall 87476 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1606-2021
Event ID87476
Event DescriptionMedtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Product TypeDevices
DistributionWorldwide distribution.
Quantity497,747 units
Recall ReasonUse of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Device Classification20210526
Device Code InfoAll Lot numbers within active shelf life
Center Classification Date20210517
Recall Initiation Date20210226
Recalling FirmMedtronic Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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