Baxter Recalls Sodium Chloride IV Solutions Due to Particulate Matter
Baxter Healthcare is voluntarily recalling 0.9% Sodium Chloride Injection IV solutions due to the presence of particulate matter, including fibers and plastic particles.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Baxter Healthcare Corporation is issuing a voluntary recall of 0.9% Sodium Chloride Injection, USP, packaged in 50 mL and 100 mL single-dose VIAFLEX plastic containers. The recall affects 716,544 containers distributed nationwide, as well as in Puerto Rico, Singapore, Saudi Arabia, and the United Arab Emirates.
The recall is being conducted due to the presence of particulate matter in the solution. The identified particles include polyester and cotton fibers, an adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene, and human hair embedded in the plastic bag.
Healthcare providers and patients should discontinue use of the affected lots and contact Baxter Healthcare for further instructions. The affected lot numbers are P297283 (Exp 08/14), P292326 (Exp 04/14), P293993 (Exp 05/14), and P293514 (Exp 04/14).
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Affected units
- 716,544
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: a) P297283
- Exp 08/14
- b) P292326
- Exp 04/14
- P293993
- Exp 05/14
- and P293514
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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