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OriGen Biomedical, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for OriGen Biomedical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-02-21FDA-DeviceClass IIAccessory 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
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.
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