Reported Nov 24, 2021 · Ongoing
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- LEEP PRECISION Integrated System, 220V
- CooperSurgical part numbersLP-10-220
- Lot codes and dates
- Serial Numbers
73 of 73 codes
201704000120170400022017040003201704000420170400052018030001201803000220180300032018030004201810000420181000052018100006201812000120181200022018120003201901000120190100022019010003201901000420190100052019030001201903000220190300032019030004201907000120190700022019070003201907000420190700052019070006201910000120191000042019100005201912000120191200022019120003201912000420191200052019120006202003000120200300022020030003202003000420200300052020060001202006000220200600032020060004202006000520200600062020080001202008000220200800032020080004202008000520200800062020110001202011000220201100032020110004
- Serial Numbers
- Amount recalled
- 75 Units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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