Recalls / Class I
Class ID-1592-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 0338-0553
- FDA application
- NDA020178
- Affected lot / code info
- Lot #: P308650, Exp 10/14
Why it was recalled
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 390,560 bags
- Distribution pattern
- Nationwide, Puerto Rico, Singapore, and Hong Kong
Timeline
- Recall initiated
- 2014-07-11
- FDA classified
- 2014-09-18
- Posted by FDA
- 2014-09-24
- Terminated
- 2016-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1592-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.