FDA Recall D-1591-2014
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 803 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1591-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide, Puerto Rico, Singapore, and Hong Kong
- Recall initiated
- 2014-07-11
- Classified by FDA Center
- 2014-09-18
- FDA published
- 2014-09-24
- Terminated
- 2016-09-21
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- SODIUM CHLORIDE
- Generic name(s)
- SODIUM CHLORIDE
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0043, 0338-0049- Route(s)
- INTRAVENOUS