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Class 2 Device Recall Cartridge Blood Set |
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Date Initiated by Firm |
April 17, 2020 |
Create Date |
June 01, 2020 |
Recall Status1 |
Terminated 3 on February 07, 2023 |
Recall Number |
Z-2193-2020 |
Recall Event ID |
85514 |
510(K)Number |
K070414 K100364
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Product Classification |
Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
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Product |
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. |
Code Information |
Product Code: 101025; UDI: 37332414007837; Lot Numbers: 1000200708, 1000203117, 1000203118, 1000203119, 1000203120, 1000203121, 1000205678, 1000205897, 1000205898, 1000205899, 1000205900, 1000205901, 1000206872, 1000206873, 1000206874, 1000208247, 1000208248, 1000208249, 1000208250, 1000210314, 1000210315, 1000210316, 1000210317, 1000210318, 1000210319, 1000210320, 1000211719, 1000211720, 1000211721, 1000211722, 1000211723, 1000211724, 1000215485, 1000215486, 1000215487, 1000215488, 1000215489, 1000215490, 1000217361, 1000217362, 1000217363, 1000217364, 1000218866, 1000218867, 1000218868, 1000218869, 1000218870, 1000218871, 1000220529, 1000220530, 1000220531, 1000220532, 1000223070, 1000223071, 1000223072, 1000223073, 1000223074, 1000225427, 1000225428, 1000225429, 1000225430, 1000225431, 1000226714, 1000226717, 1000229599 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact |
800-422-9837
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Manufacturer Reason for Recall |
Potential disconnection of tubing set.
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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 |
2,361,885 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
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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.
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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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