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Lower risk Drug recall · FDA · Published December 15, 2017

B. Braun Medical 0.25% Acetic Acid Irrigation Container Recall: Particulate Matter Hazard

B. Braun Medical recalls 500mL plastic irrigation containers with polyethylene particulate matter that could cause blockages or infections during medical use.

🇺🇸 FDA recall #D-0112-2018DrugB. Braun Medical ›
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Recalling firmB. Braun Medical Inc2525 McGaw Ave · Irvine, CA 92614-5841
✎ GovInfoNow plain-language explainer

What happened, in plain English

B. Braun Medical is recalling 500mL plastic irrigation containers that may contain polyethylene particles. This could cause blockages or infections if used for medical irrigation. Read more at govinfonow.com/recall/41012-b-braun-medical-0-25-acetic-acid-irrigation-container-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/41012-b-braun-medical-0-25-acetic-acid-irrigation-container-recall · Updated October 7, 2026 · FDA enforcement record: FDA #D-0112-2018

Cite this page

“B. Braun Medical 0.25% Acetic Acid Irrigation Container Recall: Particulate Matter Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41012-b-braun-medical-0-25-acetic-acid-irrigation-container-recall. Based on FDA recall #D-0112-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2018%22&limit=1).

Why it’s dangerous

The containers may contain polyethylene particles from the cap material. These particles could block medical irrigation lines or cause infections if they enter the patient's body.

Who’s affected

Healthcare professionals using the irrigation containers for medical procedures are most at risk. Patients receiving irrigation treatments may be affected if the containers are used.

How to tell if you have this one

Check for the 500mL plastic irrigation container with NDC 0264-2304-10 and lot number J7N965, which expired on 10/31/2020. The product was sold in the USA.

  • Brand
    B. Braun Medical
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Container Details

    Verify the product's lot number (J7N965) and expiration date (10/31/2020) to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed 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 10 months after the firm started it.

1. Firm started the recall: Dec 15, 201712. FDA classified it Class II: Dec 20, 201723. Published in FDA’s Enforcement Report: Dec 27, 201734. FDA terminated the recall: Oct 18, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-0112-2018 (December 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0112-2018 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA