0.9% Sodium Chloride: Product Name/Product Code recall: Sterility Concern
0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
Why was 0.9% Sodium Chloride: Product Name/Product Code recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, 22104234
- Product
- 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
- Recalling firm
- Nurse Assist, LLC
- Quantity
- 3,360 Cases
- Distribution
- 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
- Recall date
- December 27, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)