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
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- OriGen Biomedical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281
Distribution:
Distributed in: US, FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND, GB, NL, CH, PL, DE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1068-2024
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