LEEP PRECISION Surgical Generator May Fail to Coagulate During Surgery
CooperSurgical is recalling 75 units of the LEEP PRECISION Generator 220V because the coagulation hand switch may fail, potentially causing uncontrolled bleeding during surgery.
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: FDA Class II recall of a surgical device where the critical coagulation function may fail, potentially leading to uncontrolled intraoperative bleeding. No actual injuries or illnesses have been reported; the hazard is theoretical, fitting the rubric category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 75 units of the LEEP PRECISION Generator 220V (Part Number LP-20-220) for a potential malfunction affecting the coagulation function.
The coagulation function may not operate when using the hand switch. When this function fails, the device cannot properly coagulate tissue, which may lead to prolonged surgical procedures and uncontrolled intraoperative bleeding that requires medical intervention to control.
This surgical device has been distributed throughout the United States and internationally.
If you have this device, contact CooperSurgical, Inc. immediately for instructions on how to address this potential defect. Do not use affected units until you have received guidance from the manufacturer.
The recalled product
- Product
- LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- coagulation-failure
- intraoperative-bleeding
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 (1)
- Serial Numbers: 2018100001 2018100002 2018100003
Distribution
Distributed nationwide across the United States.
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