The Recall Desk
HighFDA (Devices)·Z-3223-2017·Announced 2017-10-04

Teleflex Percuvance Scissors Tool Tip Recall for Connection and Jaw Issues

Teleflex Medical is recalling Percuvance Scissors Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (compromised connection or abrupt jaw closure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Teleflex Medical is recalling specific lots of the Percuvance Scissors Tool Tip, a component of the Percutaneous Surgical System used in laparoscopic surgery. The recall involves 20,039 units distributed worldwide, including the United States and numerous international locations.

The recall was initiated because the security of the connection between the shaft and the tool tip may be compromised for some products. Additionally, for certain other lots, the jaws of the tool tips may close abruptly. The affected lot numbers are 73A1600602, 73C1600170, 73D1600483, 73D1600623, 73E1600174, 73F1600149, 73F1600206, 73G1600390, 73H1600006, 73H1600357, 73H1600506, 73K1600471, 73L1600034, and 73M1600327.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Teleflex Medical for further instructions on how to proceed with the recall.

The recalled product

Product
Percuvance Scissors 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 ti
Manufacturer
Teleflex Medical
Affected units
20,039

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Lot #'s: 73A1600602
  • 73C1600170
  • 73D1600483
  • 73D1600623
  • 73E1600174
  • 73F1600149
  • 73F1600206
  • 73G1600390
  • 73H1600006
  • 73H1600357
  • 73H1600506
  • 73K1600471
  • 73L1600034
  • and 73M1600327

Distribution

Part of a larger recall action

This product is one of 6 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →