—#181127

Product

Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

FDA product code: FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070414, K100364
Affected lot / code info: 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

Why it was recalled

Potential disconnection of tubing set.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2020-04-17
Terminated: 2023-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181127. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.