Recalls / Class I
Class ID-1550-2014
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, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
- Affected lot / code info
- Lot C931923, exp 8/31/2015
Why it was recalled
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 4,200 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-12
- FDA classified
- 2014-08-21
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1550-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.