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U.S. Department of Health and Human Services

Class 2 Device Recall FloThru Intraluminal Shunt

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  Class 2 Device Recall FloThru Intraluminal Shunt see related information
Date Initiated by Firm April 01, 2022
Date Posted April 29, 2022
Recall Status1 Open3, Classified
Recall Number Z-1019-2022
Recall Event ID 89897
510(K)Number K981624  
Product Classification Clamp, vascular - Product Code DXC
Product Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Code Information Product Code: FT12150; Lot: SP21J21-1584173
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 There is a potential for foreign matter.
FDA Determined
Cause 2		 Process control
Action An Urgent Medical Device Recall communication was sentt to affected customers via U.S.P.S., first class mail on 04/01/2022. Customers are advised to: 1) Locate and return any unused affected product from your facility. The product code and lot number can be found on the individual product pouch or carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. Acknowledge receipt of this notification by completing a reply form on the customer portal.
Quantity in Commerce 300 devices
Distribution Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
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 = DXC and Original Applicant = BIO-VASCULAR, INC.
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