medical Class II Updated 2024-02-21

OriGen Biomedical, Inc. recalls Accessory Sets Syringes: 6ml syringe with a female luer with

Recalled Product

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T

Hazard / Issue

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.

Issued by

FDA

Affected States: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND, DE

Lot/Code Info: REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281

View official government recall

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