Z-1144-2022Class II

Effluent Sample Bag

Name: Z-1144-2022 Effluent Sample Bag
Creator: Baxter Healthcare Corporation
Published: 2022-04-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-04-21 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of Effluent Sample Bag on 2022-04-21. FDA classified it as Class II and gives the reason as "Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1144-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-21
Posted: 2022-05-27
Terminated: 2026-05-27
Recalling firm: Baxter Healthcare Corporation
Product: Effluent Sample Bag
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
FDA root cause: No Marketing Application
Action: An Urgent Medical Device Recall communication was sent to affected peritoneal dialysis centers via U.S.P.S., first class mail on 04/21/2022. Instructions within the communication request customers to locate and return any unused affected product codes and lots from their facility, contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday, and acknowledge the receipt of this notification by completing a reply form on the customer portal or by returning a reply form in the enclosed pre-addressed stamped envelope. The home patient letter was sent on Tuesday, April 26, 2022, via USPS first-class mail.
Quantity in commerce: 78 units
Distribution: US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Product codes and lots: Product code: R5C4476; UDI: 00085412008738; Lot Number: H18E25030 (exp. date: 04/30/2023), Lot Number: H19D12097(exp. date: 03/31/2024), Lot Number: H19K14040 (exp. date: 10/31/2024),Lot Number: H20B19101 (exp. date: 01/31/2025),Lot Number: H20F17064 (exp. date: 05/31/2025),Lot Number: H20I28073 (exp. date: 08/31/2025),Lot Number: H21D01054 (exp. date: 03/31/2026),Lot Number: H21I24030 (exp. date: 08/31/2026), Lot Number: H21J13040 (exp. date:09/30/2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1144-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1141-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-27
Z-1142-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-27
Z-1143-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-27
Z-1144-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-27
Z-1145-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-27
Z-1146-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-27

Product code FKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)