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Lower risk Medical device recall · FDA · Published June 4, 2018

B. Braun 26-Lead Transfer Set Recall: Incorrect Valve Orientation Risk

B. Braun recalls 26-Lead Transfer Sets for APEX Compounding System with potential for incorrect valve orientation causing unintended drug mixtures. Check product catalog numbers listed.

🇺🇸 FDA recall #Z-2343-2018Medical deviceB. Braun ›
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Contact the company

Recalling firmB. Braun Medical, Inc.901 Marcon Blvd · Allentown, PA 18109-9512
✎ GovInfoNow plain-language explainer

What happened, in plain English

B. Braun is recalling 26-Lead Transfer Sets used with APEX Compounding Systems due to a risk of valves being incorrectly oriented. This could lead to unintended drug mixtures if the transfer set is installed improperly. Read more at govinfonow.com/recall/70907-b-braun-26-lead-transfer-set-recall-incorrect-valve-orientation.

Source Summary by GovInfoNow · govinfonow.com/recall/70907-b-braun-26-lead-transfer-set-recall-incorrect-valve-orientation · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2343-2018

Cite this page

“B. Braun 26-Lead Transfer Set Recall: Incorrect Valve Orientation Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70907-b-braun-26-lead-transfer-set-recall-incorrect-valve-orientation. Based on FDA recall #Z-2343-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2018%22&limit=1).

Why it’s dangerous

The transfer set's valves may be installed incorrectly, which can cause unintended mixing of medications. This risk occurs when the transfer set is attached to the APEX Compounding System without proper valve alignment.

Who’s affected

Healthcare professionals using the APEX Compounding System with the recalled transfer sets are most at risk. Patients receiving compounded medications through these systems may be affected if the transfer set is incorrectly installed.

How to tell if you have this one

Check for product catalog numbers: 0061546906, 0061546910, 0061548145, and other numbers listed in the recall notice. These sets were sold with the APEX Compounding System.

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

What to do — step by step

  1. Check Valve Orientation

    Inspect the transfer set for correct valve alignment before installation on the APEX Compounding System.

Where it went and when

Where it was distributed

Distributed in 20 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, North Carolina, Ohio, Pennsylvania, Texas, Washington.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Jun 4, 201812. FDA classified it Class II: Jul 3, 201823. Published in FDA’s Enforcement Report: Jul 11, 201834. FDA terminated the recall: Jan 13, 2020420182020
  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.

✎ GovInfoNow

Questions people ask

Do I need to stop using the product?

The recall does not require immediate discontinuation; users should check valve orientation before installation.

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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 #Z-2343-2018 (June 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2343-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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