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

Recall date

December 19, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1068-2024

FDA classification

Class II

Brand / firm

OriGen Biomedical, Inc.

Sold / distributed

US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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