Z-1068-2024Class II

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml...

Name: Z-1068-2024 Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml...
Creator: OriGen Biomedical, Inc.
Published: 2023-12-19
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2023-12-19 / Open, Classified / root cause: manufacturing process

FDA source

OriGen Biomedical, Inc. began a recall of 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... on 2023-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1068-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-19
Posted: 2024-02-09
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
Product code: KJG Tube, Tissue Culture
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 3613 Cases
Distribution: US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE
Product codes and lots: REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1068-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1068-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code KJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)