Z-1005-2024 Class II Ongoing
Recalled by Medtronic MiniMed, Inc.
— Northridge, CA
FDA device recall Z-1005-2024 was initiated by Medtronic MiniMed, Inc. on November 15, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 114,758.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- November 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114,758
Product Description
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of PR, AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Austria, Belgium, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Liechtenstein, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
Code Information
REF/UDI-DI/Lot: MMT-7040A/20763000413389/HG72B2C, HG72CQQ, HG73VB7, HG73VC8, HG73VFT, HG73WFR, HG7441E, HG745F9, HG7486X, HG74AJ1, HG74SUR, HG74T9Q, HG74U36, HG78LMS, HG79Y9U; MMT-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; MMT-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; MMT-7040C3/20763000555294/HG6XNH3, HG73RNR; MMT-7040D1/00763000413484/HG6THY1, HG6V7VV; MMT-7040D2/00763000413491/HG6TL44; MMT-7040MA/20763000519692/HG74460; MMT-7040QC1/00763000555313, 20763000555317/HG6WT9A, HG6WUGE, HG73PH3; MMT-7040QC2/20763000555324, 763000555320/HG6WT9A; MMT-7040QC3/20763000555331/HG6WT9A