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

FDA device recall Z-1068-2024 · posted 2024-02-09 · Open, Classified

Recall details

Recalling firm

OriGen Biomedical, Inc.

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.

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KJG

Quantity affected

3613 Cases

Distribution

US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE

Date initiated

2023-12-19

Date posted

2024-02-09

Location

Austin, TX