Baxter Recalls Potassium Chloride Injection Due to Particulate Matter
Baxter Healthcare is recalling 171,672 bags of Potassium Chloride Injection due to the presence of particulate matter, including fibers and plastics.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death, meeting the criteria for a Severe rating.
Plain-English summary
Baxter Healthcare Corporation is recalling 171,672 bags of Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag. The product is identified by Lot # P309476 and has an expiration date of 10/14. The recall was initiated because particulate matter, identified as fibers and/or plastics, was found in the product.
The affected product was distributed nationwide, as well as in Puerto Rico, Singapore, and Hong Kong. This is a prescription-only intravenous medication.
Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare for further instructions or replacement.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Injection
- Affected units
- 171,672
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 (2)
- Lot #: P309476
- Exp 10/14
Distribution
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
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