0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Reported: September 24, 2014 Initiated: July 11, 2014 #D-1591-2014
Product Description
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Reason for Recall
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- a) 217,536 bags; b) 161,760 bags
- Distribution
- Nationwide, Puerto Rico, Singapore, and Hong Kong
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.. Recalled by Baxter Healthcare Corp.. Units affected: a) 217,536 bags; b) 161,760 bags.
Why was this product recalled? ▼
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2014. Severity: Critical. Recall number: D-1591-2014.
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