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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE ReNewal

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  Class 2 Device Recall MEDLINE ReNewal see related information
Date Initiated by Firm August 03, 2023
Date Posted October 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-0119-2024
Recall Event ID 92920
510(K)Number K153745  
Product Classification Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed - Product Code NUJ
Product MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
Code Information UDI/DI 10193489189759 (each), 20888277680446 (case), Lot Numbers: 498352, 498405, 498459, 498890, 498937, 499048, 499050, 499052, 499062, 499063, 499145, 499155, 499218, 499267, 499269, 499271, 499299, 499343
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
FDA Determined
Cause 2		 Packaging
Action Medline issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem and the potential risk. Those consignees who have transferred possession of the affected product were directed to notify their customers. The firm is seeking the return of the affected product. An error in the model number was noted (missing an "R" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number.
Quantity in Commerce 268 units
Distribution US
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NUJ and Original Applicant = SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN
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