Recall Z-1068-2024— OriGen Biomedical, Inc.
Class II · Ongoing
Class II FDA medical device recall by OriGen Biomedical, Inc., initiated 2023-12-19. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- OriGen Biomedical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-19
- Firm location
- Austin, TX, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.