LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Summary
The FDA issued a Class II for LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF18 by Covidien Llc. Reason: Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential.
Details
Source
Device Recall
External ID
Z-0495-2022
Action Date
2022-01-19
Status
Terminated
Category
device
Product Description
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Lot/Code Info: UDI: 20884521705880 10884521705883; Lot Number: 11320187X
Quantity Affected: 504 devices
Reason for Recall
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
Distribution
Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-06
Company
Mansfield, MA
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 106 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 clearances.
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 Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien Llc have FDA actions?
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0495-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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