FDA Recall D-0862-2016
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 767 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, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Reason for recall
Presence of Particulate Matter: identified as cardboard.
Recall record
- Recall number
D-0862-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2016-01-21
- Classified by FDA Center
- 2016-05-23
- FDA published
- 2016-06-01
- Terminated
- 2018-02-26
- 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