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Terminated

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK

FDA Recall Z-1641-2021 · Posted 2021-05-19

Recalling FirmBIOPSYBELL S.R.L.
Recall StatusTerminated
Product CodeLOD
Date Initiated2021-03-22
Date Terminated2026-02-17
Product Quantity160 units

Reason for Recall

Products labeled as sterile were distributed, but may not have been sterilized.

Firm 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.

Root Cause

Vendor change control

Distribution Pattern

US Nationwide distribution in the states MS and KY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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