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Terminated

OMNI K1 Broach Handle, Product Code HS-10054

FDA Recall Z-0837-2019 · Posted None

Recalling FirmOMNIlife science Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2018-11-29
Date Terminated2020-04-16
Product Quantity7

Reason for Recall

There is a potential for the inner pin of the handle to become loose and fall out.

Firm Action

Customers were contacted via telephone on 11/29/18. Advisory Notice letters were also distributed to customers on 12/14/18.

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed to the following US states: CA, GA, SC, and UT.

Official Source

View FDA Recall →

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

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