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U.S. Department of Health and Human Services

Class 2 Device Recall Reinforced Dual Lumen Cannula, VV13F

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  Class 2 Device Recall Reinforced Dual Lumen Cannula, VV13F see related information
Date Initiated by Firm August 21, 2018
Create Date October 12, 2018
Recall Status1 Terminated 3 on October 05, 2021
Recall Number Z-0102-2019
Recall Event ID 81098
510(K)Number K113869  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Code Information UDI: 00816203022059, lot N18687-1
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		 The catheter failed the endotoxin testing.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action On 08/21/18, the firm emailed a recall notice to customers informing them of a nationwide recall of RDLC ECMO catheters. Customers were advised to return affected product to the firm. Customers with additional questions were advised to call 1-800-233-9014 or 1-512-474-7278. The firm also sent customers Technical Bulletin (TB) 1411 - Revision Feb 2018, Subject: Radiopacity of the Reinforced Dual Lumen Catheter (RDLC), Date: July 2015, and an Acknowledgment Receipt form to complete and return. On 09/12/18, and 09/20/18, the firm sent two additional recall notices, which included additional affected lot numbers that were not the subject of the current removal.
Quantity in Commerce 106
Distribution US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand
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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