Z-3054-2020 Class II Terminated
FDA device recall Z-3054-2020 was initiated by Medline Industries Inc on July 28, 2020 and is designated Class II. Reason for recall: Product was shipped with refrigeration (ice) instead of frozen (dry ice). The recall status is terminated (terminated February 13, 2023). Affected quantity: 118 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- July 28, 2020
- Termination Date
- February 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 units
Product Description
Control, Calibrator Verified, Triage BNP, Model ALR88755
Reason for Recall
Product was shipped with refrigeration (ice) instead of frozen (dry ice).
Distribution Pattern
Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX
Code Information
Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N