FDA Recalls LigaSure Exact Dissector Nano Coated Due to Sterile Breach
FDA is recalling 936 units of LigaSure Exact Dissector Nano Coated instruments because sterile pouches were found with punctures.
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 hazard involves a sterile breach in a surgical instrument, which poses a risk of infection or harm during surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 936 units of the LigaSure Exact Dissector Nano Coated 20.6mm-21cm. This bipolar electrosurgical instrument is intended for use in open surgical procedures to ligate and divide vessels, tissue bundles, and lymphatics.
The recall was initiated after devices were found with a sterile breach, specifically a puncture in the packaging pouch. This issue was identified during a sort of 8,064 packaged devices. The affected lots are 72550127X, 72770140X, 72770141X, and 73000048X.
The products were distributed worldwide in Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, and the United Kingdom. Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm, Covidien LLC, for instructions on return or replacement.
The recalled product
- Product
- LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
- Manufacturer
- Covidien LLC
- Affected units
- 936
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)
- Lot #s 72550127X 72770140X 72770141X 73000048X
Distribution
Distribution scope not specified by the agency.
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