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U.S. Department of Health and Human Services

Class 2 Device Recall Accessory Set Syringe/tubing (sterile)

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  Class 2 Device Recall Accessory Set Syringe/tubing (sterile) see related information
Date Initiated by Firm December 19, 2023
Date Posted February 09, 2024
Recall Status1 Open3, Classified
Recall Number Z-1068-2024
Recall Event ID 93752
Product Classification Tube, tissue culture - Product Code KJG
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
Code Information REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281
Recalling Firm/
Manufacturer
OriGen Biomedical, Inc.
7000 Burleson Rd Bldg D
Austin TX 78744-3202
For Additional Information Contact
512-474-7278
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 3613 Cases
Distribution US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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