Reported Feb 14, 2024 · Ongoing
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA,…
Medtronic MiniMed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- Guardian 4 Glucose Sensor
- REF
MMT-7040AMMT-7040C1MMT-7040C2MMT-7040C3MMT-7040D1MMT-7040D2MMT-7040MAMMT-7040QC1MMT-7040QC2MMT-7040QC3
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 20763000413389REF/UDI-DI/Lot: MMT-7040A/20763000413389/HG72B2C, HG72CQQ, HG73VB7, HG73VC8, HG73VFT, HG73WFR, HG7441E, HG745F9, HG7486X, HG74AJ1, HG74SUR, HG74T9Q, HG74U36, HG78LMS, HG79Y9U 2 007630005552760076300041339220763000413396207630005552702076300071247500763000712471MMT-7040C1/00763000555276, 00763000413392, 20763000413396, 20763000555270, 20763000712475, 00763000712471/F1323, F1923, G0323, G1723, G2023, G2623, G2923, HG6RV7S, HG6TGNU, HG6TJ2Y, HG6TW97, HG6TWVU, HG6UNF2, HG6V8NN, HG6VB8S, HG6VNX3, HG6WNE1, HG6XFPR, HG6XH54, HG6XQCG, HG6XZJX, HG6Y0W1, HG6Y3QN, HG6YEK6, HG6YFAF, HG6YFHL, HG6YJAR, HG6YJBD, HG6YNGD, HG6Z7N5, HG6ZARN, HG7038Y, HG70CW5, HG70DAM, HG70JSU, HG70LRC, HG70QWA, HG71VMZ, HG72DB5, HG72G9C, HG72NV9, HG72R1P, HG72RBD, HG72SE3, HG72TPT, HG72TRV, HG72V3J, HG72ZFP, HG7340A, HG73EJX, HG73RNR, HG745SV, HG747E3, HG7480Q, HG749N6, HG74F93, HG75TSX, HG75XA1, HG76HFH, HG76RYY 3 20763000555287MMT-7040C2/20763000555287/HG6RC39, HG6RXB5, HG6T4T7, HG6T8RV, HG6TJ2Y, HG6WKZU, HG6WLKS, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6Y5C6, HG6Z1X5, HG713AK, HG73EGX, HG73EJX, HG73FJP, HG73Q24, HG73QPM, HG73RNR, HG7619X, HG764J9, HG76CWC, HG77FMK 4 20763000555294MMT-7040C3/20763000555294/HG6XNH3, HG73RNR 5 00763000413484MMT-7040D1/00763000413484/HG6THY1, HG6V7VV 6 00763000413491MMT-7040D2/00763000413491/HG6TL44 7 20763000519692MMT-7040MA/20763000519692/HG74460 8 0076300055531320763000555317MMT-7040QC1/00763000555313, 20763000555317/HG6WT9A, HG6WUGE, HG73PH3 9 20763000555324763000555320MMT-7040QC2/20763000555324, 763000555320/HG6WT9A 10 20763000555331MMT-7040QC3/20763000555331/HG6WT9A - Amount recalled
- 114,758
Where it was sold
Why it was recalled
Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.
This product could cause temporary or reversible health problems — stop using it.
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