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Lower risk Medical device recall · FDA · Published December 28, 2017

Bard PowerPICC Provena Catheters: Possible leaks at luer hub extension leg junction

Bard Access Systems recalls PowerPICC Provena Catheters (3 Fr. Single lumen and 4 Fr. Dual Lumen) due to possible leaks at the luer hub extension leg junction. Product codes and serial numbers listed in the recall.

🇺🇸 FDA recall #Z-0536-2018Medical deviceBard Access Systems ›
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Recalling firmBard Access Systems Inc.605 N 5600 W · Salt Lake City, UT 84116-3738
✎ GovInfoNow plain-language explainer

What happened, in plain English

Bard Access Systems is recalling PowerPICC Provena Catheters (3 Fr. Single lumen and 4 Fr. Dual Lumen) because they may leak at the luer hub extension leg junction. This could lead to complications for patients using these medical devices. Read more at govinfonow.com/recall/72214-bard-powerpicc-provena-catheters-possible-leaks-at-luer-hub-extension.

Source Summary by GovInfoNow · govinfonow.com/recall/72214-bard-powerpicc-provena-catheters-possible-leaks-at-luer-hub-extension · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0536-2018

Cite this page

“Bard PowerPICC Provena Catheters: Possible leaks at luer hub extension leg junction.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/72214-bard-powerpicc-provena-catheters-possible-leaks-at-luer-hub-extension. Based on FDA recall #Z-0536-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0536-2018%22&limit=1).

Why it’s dangerous

The catheters may leak at the luer hub extension leg junction, which could cause complications for patients. This is a potential issue with the design of the catheter connections.

Who’s affected

Patients using PowerPICC Provena Catheters for medical purposes are likely affected. Those with the specific product codes and serial numbers listed in the recall are most at risk.

How to tell if you have this one

Check for product codes and serial numbers listed in the recall, such as S1274108D (REBN2334) or S9274108D (REBN2336). The catheters are packaged in a poly tray with Tyvek lid within a header bag or breather bag configuration.

  • Brand
    Bard Access Systems
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Codes

    Look for product codes like S1274108D or S9274108D on the catheter packaging or label.

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: “Distribution US 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 3.5 years after the firm started it.

1. Firm started the recall: Dec 28, 201712. FDA classified it Class II: Feb 6, 201823. Published in FDA’s Enforcement Report: Feb 14, 201834. FDA terminated the recall: Jun 14, 2021420172021
  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 #Z-0536-2018 (December 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0536-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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