FDA-Drug2013-07-10Class II
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
Baxter Healthcare Corp.
Hazard
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Sold states
Nationwide & Puerto Rico
Affected count
845,520 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-624-2013Don't want to check this manually?
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