Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surg
Summary
The FDA issued a Class II for Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, by Covidien, LP. Reason: Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery.
Details
Source
Device Recall
External ID
Z-1891-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
Product Description
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Lot/Code Info: GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Quantity Affected: 1681 units
Reason for Recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-15
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 258 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-1891-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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