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U.S. Department of Health and Human Services

Class 2 Device Recall Thermal Ligating Shears

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  Class 2 Device Recall Thermal Ligating Shears see related information
Date Initiated by Firm March 22, 2019
Create Date June 01, 2019
Recall Status1 Terminated 3 on July 30, 2020
Recall Number Z-1698-2019
Recall Event ID 82708
510(K)Number K062257  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Code Information UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076
Recalling Firm/
Manufacturer		 Microline Surgical, Inc.
50 Dunham Rd
Suite 1500
Beverly MA 01915-1882
For Additional Information Contact Scott Marchand Davis
978-922-9810
Manufacturer Reason
for Recall		 The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.
Quantity in Commerce 115 units
Distribution The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
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 = STARION INSTRUMENTS
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