Recall Z-1937-2025 ยท JTW System, Transport, Aerobic
Copan Italia
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
| Date | Jun 9, 2025 (initiated May 2, 2025) |
| Status | Open, Classified |
| Reason | Swabs for specimen collection may be prone to breakage during product usage. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 81,600 units |
| Distribution | US Nationwide distribution in the state of MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993161 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM Copan Diagnostics, Inc., Nov 9, 1999 |