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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Safe-T-Centesis Catheter Drainage Trays Recalled for Faulty Safety Indicator

Agency Publication Date: December 5, 2025
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Summary

Bard Peripheral Vascular Inc. is recalling approximately 1,240 Safe-T-Centesis 6 Fr Catheter Drainage Trays (model PIG1260T) because the safety indicators may provide incorrect readings. The indicator can show the catheter is in the sharp position when it is actually in the blunt position, which can mislead healthcare providers during fluid removal procedures. This voluntary recall was initiated by the firm to prevent potential patient harm.

Risk

The faulty indicator may lead a user to believe the device has not yet reached the fluid-filled area when it already has, which can cause significant patient discomfort, treatment delays, or serious injury to internal organs and blood vessels.

What You Should Do

  1. This recall affects Safe-T-Centesis 6 Fr Catheter Drainage Trays (REF: PIG1260T) with lot numbers 0001623320 and 0001623069 and expiration dates of November 30, 2027.
  2. Check your facility's inventory or product packaging for the specific model number (REF: PIG1260T) and the affected lot numbers listed above.
  3. Stop using the recalled device immediately.
  4. Contact Bard Peripheral Vascular Inc. or your distributor to arrange for the return, replacement, or correction of the affected trays.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Safe-T-Centesis 6 Fr Catheter Drainage Tray
Model / REF:
PIG1260T
Lot Numbers:
0001623320 (Exp 20271130)
0001623069 (Exp 20271130)
UDI:
10885403108365
Establishment #: 2020394

Manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97864
Status: Active
Manufacturer: Bard Peripheral Vascular Inc
Sold By: Medical distributors
Manufactured In: United States
Units Affected: 1240
Distributed To: California, Minnesota, Indiana, Michigan, Louisiana

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.