B. Braun Medical 250mL Sodium Chloride Injection Recall: Leaking Bags Risk
B. Braun Medical recalls 250mL 0.9% Sodium Chloride Injection (Rx only) due to leaking bags that may cause contamination. Affected lots expire May 2023 or June 2023.
Lower-risk recall
Lack of sterility assurance: leaking bags
Contact the company
What happened, in plain English
B. Braun Medical is recalling 250mL 0.9% Sodium Chloride Injection (Rx only) because leaking bags could cause contamination. This affects patients receiving the medication through IV lines. Read more at govinfonow.com/recall/35205-b-braun-medical-250ml-sodium-chloride-injection-recall-leaking-bags.
Source Summary by GovInfoNow · govinfonow.com/recall/35205-b-braun-medical-250ml-sodium-chloride-injection-recall-leaking-bags · Updated August 18, 2026 · FDA enforcement record: FDA #D-0655-2022
Cite this page
“B. Braun Medical 250mL Sodium Chloride Injection Recall: Leaking Bags Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35205-b-braun-medical-250ml-sodium-chloride-injection-recall-leaking-bags. Based on FDA recall #D-0655-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2022%22&limit=1).
Why it’s dangerous
Leaking bags can cause contamination of the medication, potentially leading to infections. The lack of sterility assurance means the product may not be safe for injection.
Who’s affected
Patients prescribed this medication by a healthcare provider. Those using the product for intravenous administration are most at risk.
How to tell if you have this one
Check for the product name '0.9% Sodium Chloride Injection USP, 250 mL Excel Container' with the lot numbers J1E086, J1E204, J1E213 (expiring May 31, 2023) or J1H137, J1H138 (expiring June 30, 2023).
- Brand
B. Braun Medical- Category
Drug
What to do — step by step
Check Product Lot Number
Look for lot numbers J1E086, J1E204, J1E213 (expiring May 31, 2023) or J1H137, J1H138 (expiring June 30, 2023) on the container.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0655-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0655-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.