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U.S. Department of Health and Human Services

Class 2 Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider, NanoCoated

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  Class 2 Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider, NanoCoated see related information
Date Initiated by Firm December 06, 2021
Date Posted January 13, 2022
Recall Status1 Terminated 3 on May 11, 2023
Recall Number Z-0495-2022
Recall Event ID 89182
510(K)Number K162941  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Code Information UDI: 20884521705880 10884521705883; Lot Number: 11320187X
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers. Customer Action Required: 1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned. 3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory and email it to rs.anzrecalls@medtronic.com We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please do not hesitate to contact Azi Hosseini on +61 428 464 838, or azi.hosseini@medtronic.com
Quantity in Commerce 504 devices
Distribution Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = COVIDIEN
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