FDA Recall D-1550-2014
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 413 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, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
Reason for recall
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Recall record
- Recall number
D-1550-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2014-05-12
- Classified by FDA Center
- 2014-08-21
- FDA published
- 2014-08-27
- Terminated
- 2015-06-29
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL