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Class 1 Device Recall ECMO Reinforced Dual Lumen Cannula |
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Date Initiated by Firm |
January 17, 2017 |
Date Posted |
June 04, 2019 |
Recall Status1 |
Terminated 3 on July 27, 2021 |
Recall Number |
Z-1228-2019 |
Recall Event ID |
82512 |
510(K)Number |
K113869
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Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product |
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F |
Code Information |
Lots: N18431, N18431-1, R19280, R19281 |
Recalling Firm/ Manufacturer |
OriGen Biomedical, Inc. 7000 Burleson Rd Bldg D Austin TX 78744-3202
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For Additional Information Contact |
512-474-7278
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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.
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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 |
72 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = Origen Biomedical, Inc.
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