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U.S. Department of Health and Human Services

Class 2 Device Recall 6F Launcher Guide Catheter

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 Class 2 Device Recall 6F Launcher Guide Cathetersee related information
Date Initiated by FirmJanuary 15, 2021
Create DateMarch 11, 2021
Recall Status1 Terminated 3 on June 15, 2023
Recall NumberZ-1245-2021
Recall Event ID 87284
510(K)NumberK021256 
Product Classification Catheter, percutaneous - Product Code DQY
ProductMedtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Code Information Lot Code: 220712186
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information ContactMedtronic Customer Service
800-716-6700
Manufacturer Reason
for Recall		Sterility may be compromised due to an unsealed pouch
FDA Determined
Cause 2		Process control
ActionMedtronic issued 15-Jan-2021 Medical Device Correction letter via UPS 2-day to consignees stating reason for recall, health risk, and action to take: Medtronic records indicate that your facility has received one or more of the affected Launcher Guide Catheters. As a result, Medtronic requests that you immediately take the following actions: "Identify and quarantine all unused affected 6F Launcher Guide Catheters as listed in the table above. "Return/Exchange all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at1-800-716-6700 to initiate a product return/exchange. Your local Medtronic Representative can assist you in thereturn of this product. "Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Questions regarding this communication, please contact your Medtronic Field Representative.
Quantity in Commerce1 unit
DistributionNationwide
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQY
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