Z-0512-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,360 Cases
Product Description
0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
Reason for Recall
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Distribution Pattern
US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada
Code Information
Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, 22104234