FDA Recall D-1593-2014
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
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
Reason for recall
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Recall record
- Recall number
D-1593-2014- 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)
- POTASSIUM CHLORIDE
- Generic name(s)
- POTASSIUM CHLORIDE
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0703, 0338-0705, 0338-0709- Route(s)
- INTRAVENOUS