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 REF UDI-DI Lots RF-T1510816203020205V23277V23278V23639
15-RF60-T10816203020571V23281
- 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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