FDA Medical Device Recalls (openFDA)
OriGen Biomedical, Inc.: 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
- Recall number
- Z-1068-2024
- Recalling firm
- OriGen Biomedical, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2023-12-19
- Posted
- 2024-02-09
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 11/19/23, recall notices were distributed to customers who were asked to do the following: 1) Identify and quarantine affected devices. 2) Further distribution or use should cease immediately. 3) Return affected devices to the recalling firm. 4) Complete and return the customer reply form via email to info@origen.com Customers with questions can contact the recalling firm at 1-800-233-9014 between the hours of 08:00 and 16:30 (CST). On 1/3/24, the firm sent out an additional recall communication removing one of the affected lot numbers.
- Quantity
- 3613 Cases
- Distribution
- US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE
- Lot, serial or model codes
- REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KJG
- Firm FEI
- 1000160256
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28