Baxter Recalls Lactated Ringers Bags Due to Metal Particulate Matter
Baxter Healthcare is recalling specific lots of Lactated Ringers Injection due to the presence of metal particulate matter.
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 source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 58,932 bags of Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags. The recall is due to the presence of particulate matter, specifically metal, in the product.
The affected product is identified by NDC 0338-0117-02 and includes lots C964619, C964056, and C964163, all with an expiration date of 7/31/2016. The product was distributed in the United States, Puerto Rico, and Bermuda.
This is an FDA Class I recall, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. Consumers and healthcare providers should stop using the affected lots and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- LACTATED RINGERS (SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE)
- Brand
- LACTATED RINGERS
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Affected units
- 58,932
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 (3)
- Lot #: C964619
- C964056 and C964163
- Exp 7/31/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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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