FDA Recall D-481-2015
Baxter Healthcare Corp · Deerfield, IL
Class I — life-threatening Terminated 862 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, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Recall record
- Recall number
D-481-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico.
- Recall initiated
- 2014-12-04
- Classified by FDA Center
- 2015-04-08
- FDA published
- 2015-04-15
- Terminated
- 2017-04-14
- 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)
0338-0553- Route(s)
- INTRAVENOUS