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Terminated

8mm FlexDex Needle Driver, Product Code FD-335 ND

FDA Recall Z-0531-2022 · Posted None

Recalling FirmFlexDex Inc.
Recall StatusTerminated
Product CodeMDM
Date Initiated2021-12-22
Date Terminated2023-07-25
Product Quantity273

Reason for Recall

The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.

Firm Action

The firm sent a letter to customers reiterating the IFU's statement "Do not use if package is damaged." This is important to ensure the sterility of the product. If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. Please forward this letter on to all those who need to be aware within your organization and to any other organizations (e.g. customers) on which this has an impact.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

n/a

Official Source

View FDA Recall →

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

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