Recall Z-0059-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Teleflex Medical
Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog Number PCVSC5 The Percuvance Percutaneous Surgical System is a family of
| Date | Oct 18, 2017 |
| Status | Terminated |
| Reason | Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. |
| Root cause | Under Investigation by firm |
| Action | Teleflex sent an Urgent Medical Device Recall 1st Notification letter dated October 18, 2017, via FedEx. The customers were instructed to take the following actions : 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will conta |
| Quantity | 3904 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM Teleflexmedical, Inc., Apr 8, 2016 |