FDAFDA · Food and drugs·Recall number Z-0866-2022
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Published April 13, 2022 · Recall initiated: February 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Distributor
- US Nationwide distribution in the states of IN, TX, and PA.
- Lot
- SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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