B. Braun Medical 1000mL Sodium Chloride Irrigation Recall: Particulate Matter Risk
B. Braun Medical recalls 1000mL plastic irrigation containers due to reported polyethylene particles. This may cause blockages or infections. Affected units have specific batch numbers and expiration dates.
Lower-risk recall
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Contact the company
What happened, in plain English
B. Braun Medical is recalling 1000mL plastic irrigation containers because customers reported polyethylene particles. This could lead to blockages or infections during medical use. Read more at govinfonow.com/recall/40807-b-braun-medical-1000ml-sodium-chloride-irrigation-recall-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/40807-b-braun-medical-1000ml-sodium-chloride-irrigation-recall-particulate-matter · Updated October 7, 2026 · FDA enforcement record: FDA #D-0549-2018
Cite this page
“B. Braun Medical 1000mL Sodium Chloride Irrigation Recall: Particulate Matter Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40807-b-braun-medical-1000ml-sodium-chloride-irrigation-recall-particulate-matter. Based on FDA recall #D-0549-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0549-2018%22&limit=1).
Why it’s dangerous
Polyethylene particles from the container cap can enter the irrigation solution. This may cause blockages or infections if the solution is used in medical procedures.
Who’s affected
Healthcare professionals and patients using prescription 0.9% Sodium Chloride Irrigation containers. Those with the specific batch number J7N912 are most at risk.
How to tell if you have this one
Check for the batch number J7N912 on the container. The product expires October 31, 2020. It's a 1000mL plastic irrigation container sold by prescription.
- Brand
B. Braun Medical- Category
Drug
What to do — step by step
Check Container Details
Look for batch number J7N912 and expiration date October 31, 2020 on the container.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 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-0549-2018 (February 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0549-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.