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Recall Observatory FDA recall evidence

Device 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

Z-1068-2024

December 19, 2023

Class II

Product summary

Firm
OriGen Biomedical, Inc.
Event
Event 93752
Status
Ongoing
Classification
Class II
Quantity
3613 Cases
Official record key
device-enforcement:Z-1068-2024

Official wording

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.

Code information: REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.