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U.S. Department of Health and Human Services

Class 2 Device Recall Bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedure

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 Class 2 Device Recall Bipolar electrosurgical instrument intended for use in minimally invasive or open surgical proceduresee related information
Date Initiated by FirmMay 07, 2024
Date PostedSeptember 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3094-2024
Recall Event ID 95126
510(K)NumberK153745 
Product Classification Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed - Product Code NUJ
ProductMedline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Code Information Item Number: LF4418CR. UDI/DI: 20888277680446 (case), 10888277680449 (each). Lot Numbers: 500376, 500379, 500380, 500381, 500382, 500504, 500506, 500548, 500559, 500652, 500695, 500874, 503004, 503289.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Potential for an incomplete seal on the packaging tray.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.
Quantity in Commerce230 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NUJ
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