10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
FDA device recall Z-1647-2021 · posted 2021-05-19 · Terminated
Recall details
- Recalling firm
- BIOPSYBELL S.R.L.
- Reason for recall
- Products labeled as sterile were distributed, but may not have been sterilized.
- Action taken
- 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.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- LOD
- Quantity affected
- 50 units
- Distribution
- US Nationwide distribution in the states MS and KY.
- Date initiated
- 2021-03-22
- Date posted
- 2021-05-19
- Date terminated
- 2026-02-17
- Location
- Mirandola, Italy
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