Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Reported: March 15, 2023 Initiated: January 25, 2023 #Z-1228-2023
Product Description
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Reason for Recall
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 264 US; 5056 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT. Recalled by Covidien, LP. Units affected: 264 US; 5056 OUS.
Why was this product recalled? ▼
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1228-2023.
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