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U.S. Department of Health and Human Services

Class 2 Device Recall Fusion Bioline Vascular Graft

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  Class 2 Device Recall Fusion Bioline Vascular Graft see related information
Date Initiated by Firm January 30, 2023
Date Posted March 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-1245-2023
Recall Event ID 91671
510(K)Number K131778  
Product Classification Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
Product Fusion Bioline Vascular Graft, Part number M00201503046B0
Code Information UDI-DI 00384409005942 Lot 25162546
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Jessica Minaya
973-709-7634
Manufacturer Reason
for Recall		 One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
FDA Determined
Cause 2		 Process control
Action On January 30, 2023, the firm notified customers via Urgent Medical Device Removal letters. Customers are asked to examine your inventory immediately for lot 25162546. Please note, the Lot number appears on the device shelf boxes only. If you have the affected lot, please stop using and remove the device from areas of use. You are entitled to a replacement at no cost to your facility. You will receive replacement upon your acknowledgement that you have product for return. Distributors who have shipped this product should notify their customers. Please contact Getinge Customer Service at 888-943-8872 between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product.
Quantity in Commerce 1 (US)
Distribution US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
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 = DSY and Original Applicant = MAQUET CARDIOVASCULAR LLC
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