Recall Z-1068-2024
OriGen Biomedical, Inc. · initiated December 19, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1068-2024
- Initiated
- December 19, 2023
- Posted by FDA
- February 9, 2024
- Product code
- KJG – Tube, Tissue Culture
- Quantity
- 3613 Cases
- Distribution
- US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE
- Recalling firm
- OriGen Biomedical, Inc., Austin, TX