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
Reported: February 21, 2024 Initiated: December 19, 2023 #Z-1068-2024
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.
Details
- Recalling Firm
- OriGen Biomedical, Inc.
- Units Affected
- 3613 Cases
- Distribution
- US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE
- Location
- Austin, TX
Frequently Asked Questions
What product 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. Recalled by OriGen Biomedical, Inc.. Units affected: 3613 Cases.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1068-2024.
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