Z-1122-2021Class II

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 -

Name: Z-1122-2021 Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 -
Creator: Baxter Healthcare Corporation
Published: 2020-12-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-12-30 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis... on 2020-12-30. FDA classified it as Class II and gives the reason as "complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1122-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-30
Posted: 2021-02-16
Recalling firm: Baxter Healthcare Corporation
Product: Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - 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: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
FDA root cause: Under Investigation by firm
Action: The firm issued a Safety Alert on 12/30/2020 by mail. The letter explained the problem with photographs, and the hazard involved with using a device with a kinked line. Customers identifying set with kinked tubing may 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. Distributor were asked to notify their customers by distributing the letter.
Quantity in commerce: 57825 devices
Distribution: Worldwide distribution.
Product codes and lots: UDI 07332414112394, All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-16
Z-1119-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-16
Z-1120-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-16
Z-1121-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-16
Z-1122-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-16
Z-1123-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-16

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)