Teleflex Percuvance Maryland Dissector Tool Tip Recall for Connection Issues
Teleflex Medical is recalling Percuvance Maryland Dissector 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 for risk-of-harm products.
Plain-English summary
Teleflex Medical is recalling 20,039 units of the Percuvance Maryland Dissector Tool Tip, part of the Percutaneous Surgical System with 5mm attachments. The product is indicated for penetrating soft tissue to access areas of the abdomen and is used to grasp, manipulate, cut, cauterize, and deliver Hem-o-lok ligating clips during laparoscopic surgery.
The recall is due to potential safety issues with the tool tips. 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 units were distributed worldwide, including in the United States and various international locations. Specific lot numbers are listed in the recall documentation. Consumers and healthcare providers should stop using the affected products and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Percuvance Maryland Dissector 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
- 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 (15)
- Lot #'s: 73D1600174
- 73D1600587
- 73E1600661
- 73F1600015
- 73G1600729
- 73H1600012
- 73H1600149
- 73H1600341
- 73H1600902
- 73J1600062
- 73L1600025
- 73L1600210
- 73L1600445
- 73M1500036
- and 73M1500036
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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