Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brands
- SODIUM CHLORIDE, Becton Dickinson and Company
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SODIUM CHLORIDE, Becton Dickinson and Company
- Product type
- Intravenous Injection Solution (Sodium Chloride 0.9%)
- Model numbers
- Batch# 6402290, 6402291, Exp Date: 01/31/2028, Batch# 6402411, Exp Date: 02/29/2028, Batch# 6402412, 6402419, 6402424 +11 more
- UPC codes
- 17271-701, 17271-701-02, 17271-701-03, 17271-701-05, 17271-701-06, 17271-701-07
- Sizes
- 250 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 11, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
IV saline solution supplied in single-dose freeflex bags is used to restore fluid balance in patients. It is distributed nationwide and used in hospitals and clinics.
Why This Is Dangerous
Lack of assurance of sterility means the solution could be contaminated with bacteria or other pathogens, posing infection risk to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the provided material.
Real-World Impact
Immediate action required for healthcare facilities to prevent potential infections. No reported injuries yet, but breaches in sterility could have severe consequences in clinical settings.
Practical Guidance
Where to find product info
FDA enforcement notice for D-0431-2026 and manufacturer communications
What timeline to expect
Refund or replacement timelines not specified in provided data; recipients should follow recall notice guidance and contact supplier for status
If the manufacturer is unresponsive
- Escalate to FDA recall contacts
- Document all communications
- Consider consulting hospital compliance or legal counsel
How to prevent similar issues
- Verify sterility assurances when sourcing IV solutions
- Rely on trusted manufacturers with transparent sterility testing
- Implement recall check processes for IV products
Documentation advice
Retain lot numbers, batch IDs, expiry dates, procurement records, and all communications with supplier.
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Product Details
Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag. Sold Rx only. Distributor: BD Becton, Dickinson and Company. Manufactured by: Fresenius Kabi USA, LLC. NDC: 17271-701-05. Distribution: US nationwide including Alaska and Puerto Rico. Class II recall. Recall date: 2026-03-11. Report date: 2026-04-15.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 900 mg per 100 mL concentration in 250 mL single-dose freeflex bags
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Safety Guide
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