Summary
The FDA issued a Class II for Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT by Covidien, LP. Reason: Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transect.
Details
Source
Device Recall
External ID
Z-1228-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Lot/Code Info: UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y
Quantity Affected: 264 US; 5056 OUS
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-25
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1228-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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