Baptist Health Recalls Sodium Chloride IV Bags Due to Sterility Concerns
Baptist Health Medical Towers Pharmacy is recalling 0.9% Sodium Chloride IV bags in Arkansas due to a lack of sterility assurance.
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 3/5 (High).
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 high-risk product (IV fluids) with a sterility defect, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas, is recalling 0.9% Sodium Chloride bags intended for intravenous use. The recall involves 500 mL, 2000 mL, and 3000 mL bags. The total quantity recalled is nine bags: six 500 mL bags, one 2000 mL bag, and two 3000 mL bags.
The recall was initiated due to a lack of sterility assurance. The source text does not specify the exact cause of the sterility failure or report any specific illnesses or injuries. The affected product is distributed in Arkansas and includes all product remaining within its expiry date.
Consumers and healthcare facilities should stop using the affected IV bags and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
- Category
- Drug — IV Fluids
- Hazard
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 (1)
- All product remaining within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 38 recalled by Baptist Health Medical Towers Pharmacy and Infusion Services 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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