6ml Syringe to SCD Tube Accessory Set RF-T15Recalls & reported problems
Origen Biomedical, Inc. · 6ml syringe on a female luer with 15cm sealed SCD tubing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10816203020205), received between Dec 8, 2023 and Jan 3, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2023Class IIOpen, Classified
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.
Z-1068-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2024Material Discolored; Material Discolored
CUSTOMER REPORTED THAT A 6 ML SYRINGE (PART #: RF-T15) WAS RECEIVED DISCOLORED (YELLOW). THIS PRODUCT WAS A REPLACEMENT FOR PREVIOUS COMPLAINED PRODUCT THAT HAD THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18436256 ↗MalfunctionDec 8, 2023Material Discolored; Material Discolored
CUSTOMER REPORTED THAT A 6ML SYRINGE (PART #: RF-T15) WAS RECEIVED DISCOLORED (YELLOW) AND WITH LOOSE PLUNGERS. THE ISSUE WAS DISCOVERED AT INCOMING INSPECTION AND DID NOT INVOLVE A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18291823 ↗
Other Tube, Tissue Culture devices
- 60ml Syringe, FLL X SCD 15-RF60-TOrigen Biomedical, Inc. · Tube, Tissue Culture1 recall0 reports
- Spike Coupler 2S-P20Origen Biomedical, Inc. · Tube, Tissue Culture1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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