Z-1937-2025 Class II Ongoing
FDA device recall Z-1937-2025 was initiated by Copan Italia on May 2, 2025 and is designated Class II. Reason for recall: Swabs for specimen collection may be prone to breakage during product usage. The recall status is ongoing. Affected quantity: 81,600 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,600 units
Product Description
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Reason for Recall
Swabs for specimen collection may be prone to breakage during product usage.
Distribution Pattern
US Nationwide distribution in the state of MD.
Code Information
Lot: 2415377/UDI: 38053326002145