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U.S. Department of Health and Human Services

Class 1 Device Recall Reinforced Dual Lumen Cannula

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  Class 1 Device Recall Reinforced Dual Lumen Cannula see related information
Date Initiated by Firm March 30, 2015
Date Posted November 07, 2018
Recall Status1 Terminated 3 on March 01, 2024
Recall Number Z-0269-2019
Recall Event ID 81164
510(K)Number K113869  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473

Product Usage:
The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Code Information Product Code UDI Lot VV19F 00816203022097 N18394 
Recalling Firm/
Manufacturer		 OriGen Biomedical, Inc.
7000 Burleson Rd Bldg D
Austin TX 78744-3202
For Additional Information Contact Tonia Wilson
512-615-7630
Manufacturer Reason
for Recall		 Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On April 1, 2015 the firm sent an MEDICAL DEVICE MARKET WITHDRAWAL to customers/distributors via email to inform them the catheters may start to show signs of failure at the junction of the clear extension tube and blue hub connection that can be recognized by air entrainment or blood leakage. If the preliminary failure is identified, the catheter should be replaced immediately. Serious injuries could occur due to the failure mode. The customers are instructed to discontinue use of all products from the affected lot and to return any unused products immediately and to complete and return the acknowledgement and receipt form even if the customer does not currently have products in its inventory. The firm is conducting an investigation to determine root cause of the failure and will notify the customers when the investigation has been completed and when replacement products are available. If customers have any questions regarding the return of product or the status of the investigation, they can contact: OriGen Biomedical Attn: Bernie R Silvers 7000 Burleson Road, Building D Austin, TX 78744 Phone Number +1 512-474-7278
Quantity in Commerce 134
Distribution Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = Origen Biomedical, Inc.
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