Date Initiated by Firm |
August 02, 2017 |
Date Posted |
October 20, 2017 |
Recall Status1 |
Terminated 3 on February 29, 2024 |
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 |
Mr. Sam Saleh 512-474-7278 Ext. 206
|
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
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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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