BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
- Recall Initiated
- May 2, 2025
- Posted
- June 9, 2025
- Recall Number
- Z-1937-2025
- Quantity
- 81,600 units
Reason for Recall
Swabs for specimen collection may be prone to breakage during product usage.
Distribution
US Nationwide distribution in the state of MD.
Lot / Code Info
Lot: 2415377/UDI: 38053326002145
Root Cause
Nonconforming Material/Component
Action Taken
On May 2, 2025, Copan Italia Spa issued a Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Copan asked consignees to take the following steps: 1. Trace and dispose of all affected products 2. Disposal must be carried out according to local regulations. Evidence or declaration of Product disposal must be returned in writing 3. This notice should be passed on to all those who need to be aware within your organization. if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter and submit the acknowledgment form.