FDAFDA · Food and drugs·Recall number Z-1909-2021
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Published June 30, 2021 · Recall initiated: April 29, 2021
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
No 510k for the product to be used in a natural or surgical opening to the body
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Distributor
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Lot
- Lot Numbers: 1912E126 2002E133 2008E227 2008E226
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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