BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
FDA device recall Z-1937-2025 · posted 2025-06-09 · Open, Classified
Recall details
- Recalling firm
- Copan Italia
- Reason for recall
- Swabs for specimen collection may be prone to breakage during product usage.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JTW
- Quantity affected
- 81,600 units
- Distribution
- US Nationwide distribution in the state of MD.
- Date initiated
- 2025-05-02
- Date posted
- 2025-06-09
- Location
- Brescia, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (K993161) | Copan Diagnostics, Inc. | 1999-11-09 |