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Lower risk Medical device recall · FDA · Published September 1, 2022

B Braun Introcan Safety FEP 14G May Leak at Catheter Hub

B Braun recalls Introcan Safety FEP 14G catheters due to potential leakage at the hub. Affected units have specific product codes and expiration dates. Contact for return or repair.

🇺🇸 FDA recall #Z-0009-2023Medical deviceB Braun ›
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Recalling firmB Braun Medical Inc200 Boulder Dr · Breinigsville, PA 18031-1532
✎ GovInfoNow plain-language explainer

What happened, in plain English

B Braun is recalling Introcan Safety FEP 14G catheters because they may leak at the catheter hub. This could lead to infection or other complications if the leak causes fluid to enter the bloodstream. Read more at govinfonow.com/recall/60095-b-braun-introcan-safety-fep-14g-may-leak-at-catheter.

Source Summary by GovInfoNow · govinfonow.com/recall/60095-b-braun-introcan-safety-fep-14g-may-leak-at-catheter · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0009-2023

Cite this page

“B Braun Introcan Safety FEP 14G May Leak at Catheter Hub.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/60095-b-braun-introcan-safety-fep-14g-may-leak-at-catheter. Based on FDA recall #Z-0009-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2023%22&limit=1).

Why it’s dangerous

The catheter hub may leak fluid, which could enter the bloodstream and cause infection or other complications. This leakage risk is specific to the design of the catheter hub in the recalled model.

Who’s affected

Healthcare professionals using the Introcan Safety FEP 14G catheters for medical procedures are most at risk. Patients receiving these catheters may also be affected if leaks occur.

How to tell if you have this one

Check for the product code 4251890-02 on the catheter packaging. The catheter has a specific expiration date range from April 2027 to May 2027.

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

What to do — step by step

  1. Check Product Code

    Look for the product code 4251890-02 on the catheter packaging or label.

  2. Contact Manufacturer

    Reach out to B Braun Medical Inc for instructions on returning or repairing the catheter.

Where it went and when

Where it was distributed

Distributed in 15 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: yesMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Florida, Georgia, Maryland, Michigan, Mississippi, Missouri, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Sep 1, 202212. FDA classified it Class II: Oct 6, 202223. Published in FDA’s Enforcement Report: Oct 12, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this catheter safe to use?

The recall indicates a potential leakage risk at the catheter hub, so it is not recommended for use until the manufacturer provides a remedy.

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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-0009-2023 (September 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0009-2023 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.
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