Z-3220-2017 Class II Terminated

Recalled by Teleflex Medical — Morrisville, NC

FDA device recall Z-3220-2017 was initiated by Teleflex Medical on July 19, 2017 and is designated Class II. Reason for recall: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may… The recall status is terminated (terminated October 6, 2020). Affected quantity: 20,039 total (US and OUS).

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
July 19, 2017
Termination Date
October 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,039 total (US and OUS)

Product Description

Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Reason for Recall

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

Distribution Pattern

Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa

Code Information

Lot #'s: 73A1600601, 73A1700239, 73C1600705, 73E1600177, 73E1600177, 73E1600341, 73F1600411, 73F1600695, 73G1600727, 73H1600151, 73H1600342, and 73H1600660