Z-2337-2025 Class II Ongoing
FDA device recall Z-2337-2025 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Jul 30, 2025 and is designated Class II. Reason for recall: Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices. The recall status is ongoing. Affected quantity: 5 kits.
Recall details
- Product Type
- Devices
- Report Date
- Aug 27, 2025
- Initiation Date
- Jul 30, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 kits
Product description
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Reason for recall
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Distribution pattern
US Nationwide distribution in the state of Georgia.
Code information
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2337-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026