Z-1640-2021Class II
8G Direct Working Cannula Bevel Tip, Code Intvm-Dwcb
Biopsybell S.r.l. / initiated 2021-03-22 / Terminated / root cause: supplier
BIOPSYBELL S.R.L. began a recall of 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB on . FDA classified it as Class II and gives the reason as "Products labeled as sterile were distributed, but may not have been sterilized". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-1640-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Biopsybell S.r.l.
- Product
- 8G Direct Working Cannula Bevel Tip, Code Intvm-Dwcb
- Product code
- LOD Bone Cement
- Reason for recall
- Products labeled as sterile were distributed, but may not have been sterilized.
- Root cause tag
- supplier
- FDA root cause
- Vendor change control
- Action
- The firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them.
- Quantity in commerce
- 30 units
- Distribution
- US Nationwide distribution in the states MS and KY.
- Product codes and lots
- LOT: 20061432
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1631-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1632-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1633-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1634-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1635-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1636-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1637-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1638-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1639-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1640-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1641-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1642-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1643-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1644-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1645-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1646-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1647-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1648-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1649-2021 | Class II | Terminated | Voluntary: Firm initiated |
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