FDA Recall D-1211-2015
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
Lactated Ringers Injection, USP, 250mL VIAFELX 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 0338-0117-02
Reason for recall
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall record
- Recall number
D-1211-2015- 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)
- LACTATED RINGERS
- Generic name(s)
- SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE
- Manufacturer(s)
- Baxter Healthcare Company
- NDC(s)
0338-0117- Route(s)
- INTRAVENOUS