May 2014 FDA Recall Drug by Baxter Healthcare Corp.
D-1550-2014 - Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
This Class I drug recall was voluntarily initiated by Baxter Healthcare Corp. on May 12, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; blue polyisoprene shavings found inside the bag port tubes. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1550-2014
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
05-12-2014
08-27-2014
4,200 containers
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-29-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
Batch or Lot Expiration Information
Lot# Lot C931923, exp 8/31/2015
