FDA Recall D-1336-2015
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 503 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, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
Reason for recall
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall record
- Recall number
D-1336-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2015-07-17
- Classified by FDA Center
- 2015-08-14
- FDA published
- 2015-08-26
- Terminated
- 2016-12-01
- 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