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U.S. Department of Health and Human Services

Class 2 Device Recall Vasoview 6 Pro

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  Class 2 Device Recall Vasoview 6 Pro see related information
Date Initiated by Firm September 19, 2023
Date Posted November 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-0210-2024
Recall Event ID 93297
510(K)Number K091733  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Code Information UDI-DI: 00607567700239, Lot: 3000313857.
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Getinge Customer Service
888-880-2874
Manufacturer Reason
for Recall		 Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Removal notice was sent October 06, 2023 advising customers examine inventory, stop using, and remove any affected product from areas of use and return it to Getinge through Customer Service (888) 880-2874 between 6:00AM - 5:00PM PST. The notification should be forwarded to any system users and to any customers to which product was further distributed to. Complete and return the acknowledgement form to VV6proPkg2023.act@getinge.com or fax to (866) 326-9165.
Distribution US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
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 = GEI and Original Applicant = MAQUET CARDIOVASCULAR, LLC
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