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U.S. Department of Health and Human Services

Class 2 Device Recall 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port

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  Class 2 Device Recall 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port see related information
Date Initiated by Firm March 11, 2014
Date Posted April 02, 2014
Recall Status1 Terminated 3 on January 28, 2016
Recall Number Z-1325-2014
Recall Event ID 67819
510(K)Number K121380  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R.

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Code Information Lots - Catalog No. 40591OR - 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373; Catalog No. 405912R - 01H1200064, 01K1200379, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A130042001A1300545, 01F1300136
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael T. Taggart
919-433-4816
Manufacturer Reason
for Recall		 Complaints of leakage of insufflation gas through the device.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Letters were issued on March 11, 2014 to customers informing them of the recall. The letter asked the consignee to immediately discontinue use and quarantine any products on hand. The letter included a Recall Acknowledgement Form which is to be returned. A letter was also issued to distributors on March 11, 2014, requesting them to conduct a sub-recall.
Quantity in Commerce 55,521 total
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
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 = GCJ and Original Applicant = Teleflex Medical, Inc.
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