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

• Date Initiated by Firm: March 11, 2014
• Date Posted: April 02, 2014
• Recall Status: Terminated 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: 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