Device product
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Z-1937-2025
Product summary
- Firm
- Copan Italia
- Event
- Event 96807
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 81,600 units
- Official record key
device-enforcement:Z-1937-2025
Official wording
Reason: Swabs for specimen collection may be prone to breakage during product usage.
Code information: Lot: 2415377/UDI: 38053326002145
Distribution pattern: US Nationwide distribution in the state of MD.
Derived failure modes
-
Unknown
Swabs for specimen collection may be prone to breakage during product usage.