FDA Recall D-1208-2015
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 686 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, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Reason for recall
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall record
- Recall number
D-1208-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US, Puerto Rico, and Bermuda
- Recall initiated
- 2015-03-24
- Classified by FDA Center
- 2015-07-06
- FDA published
- 2015-07-15
- Terminated
- 2017-02-07
- 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