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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Bard Peripheral Vascular Inc: Hemodialysis Catheter Guidewires Recalled Due to Manufacturing Assembly Error

Agency Publication Date: September 6, 2024
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Summary

Bard Peripheral Vascular Inc is recalling 625 guidewires used with 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters because they were manufactured and assembled incorrectly. The stiff end of the wire is located where the flexible end should be, which can lead to serious injury if a medical provider unknowingly inserts the stiff end into a patient. These products were distributed worldwide, including in Ohio, Texas, and West Virginia, and were sold under catalog number 5583705.

Risk

If the stiff proximal end of the guidewire is mistakenly inserted into a patient instead of the intended flexible end, it can cause vascular perforation, internal bleeding, or other serious tissue damage.

What You Should Do

  1. Check your medical supplies for Guidewire 70cm x 1mm (0.038) with Catalog Number 5583705.
  2. Verify if your product matches one of the following affected Lot Numbers: REGZ2564, REFV0870, REFU4050, REFT3309, REEX1002, REEW2740, REEV0897, REDY2576, REEU1584, REER0990, or REEQ0825.
  3. Immediately stop using any guidewires from the affected lots and quarantine them to prevent accidental use during medical procedures.
  4. Contact your healthcare provider or Bard Peripheral Vascular Inc at 1-888-463-6332 for specific instructions on returning the defective units and obtaining replacements.
  5. For further information or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Medical Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Guidewire 70cm x 1mm (0.038 ) REF 5583705
Model / REF:
5583705
UPC Codes:
00801741085451
Lot Numbers:
REGZ2564
REFV0870
REFU4050
REFT3309
REEX1002
REEW2740
REEV0897
REDY2576
REEU1584
REER0990
REEQ0825

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95039
Status: Active
Manufacturer: Bard Peripheral Vascular Inc
Sold By: Direct distribution to medical facilities
Manufactured In: United States
Units Affected: 625 units
Distributed To: Ohio, Texas, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.