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Terminated

Mammary Nodules Localization

FDA Recall Z-2491-2021 · Posted None

Recalling FirmM.D.L. S.r.l.
Recall StatusTerminated
Product CodeGDF
Date Initiated2021-08-05
Date Terminated2026-05-04
Product Quantity320 units

Reason for Recall

Sterility assurance may be compromised.

Firm Action

The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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