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U.S. Department of Health and Human Services

Class 1 Device Recall Reinforced Dual Lumen Cannula, 28Fr

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  Class 1 Device Recall Reinforced Dual Lumen Cannula, 28Fr see related information
Date Initiated by Firm August 02, 2017
Create Date October 20, 2017
Recall Status1 Open3, Classified
Recall Number Z-0021-2018
Recall Event ID 78033
510(K)Number K113869  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Code Information Lot Numbers: N18487, N18487-1
Recalling Firm/
Manufacturer
OriGen Biomedical, Inc.
7000 Burleson Rd Bldg D
Austin TX 78744-3202
For Additional Information Contact Jackie Jaskula
512-615-7613
Manufacturer Reason
for Recall
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
FDA Determined
Cause 2
Under Investigation by firm
Action The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit.
Quantity in Commerce 180 units
Distribution US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.
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.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = Origen Biomedical, Inc.
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