Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns
Baxter Healthcare is recalling specific lots of Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Baxter Healthcare Corp. is recalling specific lots of Sodium Chloride Injection, USP. The affected products are available in 50 mL and 100 mL Viaflex containers in various pack configurations (Quad, Single, and Multi Pack). The recall covers 1,788,292 units distributed nationwide and in Puerto Rico.
The recall is 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 may allow contaminants to enter the product.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and expiration dates listed in the recall notice. If the affected products are found, they should be quarantined and not used. Consumers should contact their healthcare provider for guidance on alternative treatments if they have received these products.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Hazard
- Affected units
- 1,788,292
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 (18)
- Lot #: a) Product code 2B1301: P279943
- P280370
- Exp 7/13
- b) Product code 2B1302: P280248
- P280248A
- P280248B
- P285346
- P285791
- Exp 8/13
- c) Product code 2B1306: P285601
- Exp 5/13
- d) Product code 2B1307: P280347
- e) Product code 2B1308: P280404
- P280404A
- P285635
- P285858
- Exp 11/13
- e) Product code 2B1309: P280149
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.
See all 6 products in this recall →Related recalls
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