Reported Feb 21, 2024 · Ongoing

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a…

OriGen Biomedical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: OriGen Biomedical, Inc. · 7000 Burleson Rd Bldg D · Austin, TX · 78744-3202

Is this the product you have?

  • Accessory Sets Syringes6ml syringe with a female luer with 15cm sealed SCD tubing
  • REFRF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing
  • REF15-RF60-T
Lot codes and dates

2 of 2 products · 4 lot codes

Recalled lot codes, grouped by product number
REFUDI-DILots
RF-T1510816203020205
  • V23277
  • V23278
  • V23639
15-RF60-T10816203020571
  • V23281
Amount recalled
3613 Cases

Where it was sold

Why it was recalled

Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.