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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 Cannulasee related information
Date Initiated by FirmJanuary 17, 2017
Date PostedJune 04, 2019
Recall Status1 Terminated 3 on July 27, 2021
Recall NumberZ-1227-2019
Recall Event ID 82512
510(K)NumberK113869 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Code Information Lots: N18446, N18640-1, R19208, R19406
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
ActionOn 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 Commerce260
DistributionUS: 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 CycleTPLC 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) Database510(K)s with Product Code = DWF
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