Z-1684-2021Class II

Gambro Cartridge Blood Set, Product Code 101025 -

Name: Z-1684-2021 Gambro Cartridge Blood Set, Product Code 101025 -
Creator: Baxter Healthcare Corporation
Published: 2021-04-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-04-14 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems on 2021-04-14. FDA classified it as Class II and gives the reason as "There is a potential leak between the venous patient connector and patient's hemodialysis access". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1684-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-14
Posted: 2021-05-26
Terminated: 2024-05-10
Recalling firm: Baxter Healthcare Corporation
Product: Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: There is a potential leak between the venous patient connector and patient's hemodialysis access.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email.
Quantity in commerce: 17,487 units
Distribution: Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Product codes and lots: Product Code: 101025; Lot 1000276191, UDI: 37332414007837

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1684-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1684-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-26

Product code FJK

K070414Class IIGambro Cartridge Blood SetsGambro Renal Products / cleared 2007-10-12

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)