FDA Recall D-1162-2014
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 1035 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
Reason for recall
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Recall record
- Recall number
D-1162-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
- Recall initiated
- 2013-11-21
- Classified by FDA Center
- 2014-03-14
- FDA published
- 2014-03-26
- Terminated
- 2016-09-21
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- DEXTROSE
- Generic name(s)
- DEXTROSE MONOHYDRATE
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0017, 0338-0023- Route(s)
- INTRAVENOUS