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U.S. Department of Health and Human Services

Class 1 Device Recall ECMO Reinforced Dual Lumen Cannula

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  Class 1 Device Recall ECMO Reinforced Dual Lumen Cannula see related information
Date Initiated by Firm January 17, 2017
Date Posted June 04, 2019
Recall Status1 Terminated 3 on July 27, 2021
Recall Number Z-1229-2019
Recall Event ID 82512
510(K)Number K113869  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
Code Information Lots: P18806, R19368
Recalling Firm/
Manufacturer		 OriGen Biomedical, Inc.
7000 Burleson Rd Bldg D
Austin TX 78744-3202
For Additional Information Contact
512-474-7278
Manufacturer Reason
for Recall		 Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
FDA Determined
Cause 2		 Process control
Action On 01/17/2017, Technical Bulletin 17.01 was mailed to customers. Customers were informed to clamp all sizes of catheters only in the middle. The following contact information was provided: US: 1-512-474-7278, and Germany: +49-7475-915591.
Quantity in Commerce 66
Distribution US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
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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