FDAFDA · Food and drugs·Recall number Z-0837-2019
OMNI K1 Broach Handle, Product Code HS-10054
Published February 20, 2019 · Recall initiated: November 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for the inner pin of the handle to become loose and fall out.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- OMNIlife science Inc.
- Distributor
- The products were distributed to the following US states: CA, GA, SC, and UT.
- Lot
- Lot Number MM0118
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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