Drug recall
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml…
FDA recall event 93752 · Class II · OriGen Biomedical, Inc.
Key facts
| Event ID | 93752 |
|---|---|
| Recall numbers | Z-1068-2024 |
| Recalling firm | OriGen Biomedical, Inc. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 19, 2023 |
| Report date | Feb 21, 2024 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000160256 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: