Z-2196-2020Class II

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set -

Name: Z-2196-2020 Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set -
Creator: Baxter Healthcare Corporation
Published: 2020-04-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-04-17 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis... on 2020-04-17. FDA classified it as Class II and gives the reason as "Potential disconnection of tubing set". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2196-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-17
Posted: 2020-06-01
Terminated: 2023-02-07
Recalling firm: Baxter Healthcare Corporation
Product: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Potential disconnection of tubing set.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected], 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: 4,065
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
Product codes and lots: Product Code: 114435; UDI: 37332414112401; Lot Numbers: 1000212228, 1000215484, 1000224531

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2196-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2193-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-01
Z-2194-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-01
Z-2195-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-01
Z-2196-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-01

Product code FJK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)