Teleflex Percuvance Gripper Grasper Tool Tip Recall for Connection Issues
Teleflex Medical is recalling 20,039 Percuvance Gripper Grasper 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 mechanical failure (compromised connection or abrupt jaw closure) during surgery, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 20,039 units of the Percuvance Gripper Grasper Tool Tip. The product is part of a Percutaneous Surgical System used during laparoscopic surgery to grasp, manipulate, cut, cauterize, and deliver Hem-o-lok ligating clips to soft tissue in the abdomen.
The recall was initiated because the security of the connection between the shaft and the tool tip may be compromised for some of the recalled products. For certain other recalled lots, the jaws of the tool tips may close abruptly. The affected lots are 73A1600103, 73B1600340, 73C1600290, 73C1600451, 73E1600256, 73G1600559, 73G1600726, 73H1600147, 73H1600340, 73H1600900, 73J1600599, 73K1600501, 73L1600558, and 73M1500034.
The products were distributed worldwide, including in the United States and various international locations. Healthcare providers and facilities should stop using the affected products and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Percuvance Gripper Grasper 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
- 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: 73A1600103
- 73B1600340
- 73C1600290
- 73C1600451
- 73E1600256
- 73G1600559
- 73G1600726
- 73H1600147
- 73H1600340
- 73H1600900
- 73J1600599
- 73K1600501
- 73L1600558
- and 73M1500034.
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.
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