Z-0768-2023 Class II Ongoing
FDA device recall Z-0768-2023 was initiated by Acumed LLC on November 29, 2022 and is designated Class II. Reason for recall: Distribution without Pre-Market Clearance The recall status is ongoing. Affected quantity: 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048).
Recall Details
- Product Type
- Devices
- Report Date
- January 4, 2023
- Initiation Date
- November 29, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, 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, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.