The Recall Desk
HighFDA (Devices)·Z-3220-2017·Announced 2017-10-04

Teleflex Recalls Percuvance Clip Applier Tool Tips Due to Connection Issues

Teleflex Medical is recalling 20,039 Percuvance Clip Applier 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 is classified as FDA Class II, and the source describes a risk-of-harm product (surgical instrument malfunction) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Teleflex Medical is recalling 20,039 units of the Percuvance Clip Applier Tool Tip. This medical device is part of the Percutaneous Surgical System with 5mm attachments, indicated for penetrating 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.

The recall was initiated because, 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, the jaws of the tool tips may close abruptly.

The affected products were distributed worldwide, including in the United States and various international locations. The specific lot numbers involved are 73A1600601, 73A1700239, 73C1600705, 73E1600177, 73E1600341, 73F1600411, 73F1600695, 73G1600727, 73H1600151, 73H1600342, and 73H1600660. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product
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 sof
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 (11)

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

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 →