Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns
Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an IV drug) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corp. is recalling specific lots of 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container. The affected products are 50 mL and 100 mL units, identified by specific product codes and expiration dates of May 2013. The recall covers 845,520 units distributed nationwide and in Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. A manufacturing issue occurred during the sealing of the closure assembly at the administration port, creating a potential for leakage. This defect could compromise the sterile integrity of the intravenous solution.
Healthcare providers and patients should stop using the affected lots immediately. The source text does not specify additional consumer actions or report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Intravenous Solution
- Affected units
- 845,520
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 (6)
- Lot #: a) Product code 2B0042: P285668
- P285668A
- P285668C
- P285734
- Exp 5/13
- b) Product code 2B0043: P285395
Distribution
Part of a larger recall action
This product is one of 6 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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