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U.S. Department of Health and Human Services

Class 2 Device Recall Cartridge Blood Set

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  Class 2 Device Recall Cartridge Blood Set see related information
Date Initiated by Firm April 17, 2020
Create Date June 01, 2020
Recall Status1 Terminated 3 on February 07, 2023
Recall Number Z-2195-2020
Recall Event ID 85514
510(K)Number K070414  K100364  
Product Classification Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
Product Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Code Information Product Code: 114434; UDI: 47332414112395; Lot Numbers: 1000201510, 1000206870, 1000214235, 1000218202, 1000224530 
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
800-422-9837
Manufacturer Reason
for Recall		 Potential disconnection of tubing set.
FDA Determined
Cause 2		 Process control
Action Baxter Healthcare notified customers on about 04/17/2020 via "Urgent Device Correction" letter. Customers were instructed to do the following: 1. Prior to use, thoroughly inspect each connection of the set to check for any detachments in the tubing. Operators may continue to use affected sets if no detachments are observed. Additionally, per the Instructions For Use (IFU), users should observe carefully for leaks during priming and use, and examine the tubing carefully to be certain that all connections are secure, all lines are unobstructed and that there are no kinks or leaks in the tubing. 2. If you find sets with tubing disconnections, please 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. If you purchased affected product directly from Baxter, a customer reply form is included in your mailing. Please complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that
Quantity in Commerce 19,800 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FJK and Original Applicant = GAMBRO RENAL PRODUCTS
510(K)s with Product Code = FJK and Original Applicant = GAMBRO RENAL PRODUCTS, INC.
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