Z-1291-2024Class II

CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

Name: Z-1291-2024 CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Creator: Baxter Healthcare Corporation
Published: 2024-02-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-02-08 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 on 2024-02-08. FDA classified it as Class II and gives the reason as "Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1291-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-08
Posted: 2024-03-14
Recalling firm: Baxter Healthcare Corporation
Product: CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Product code: FPA Set, Administration, Intravascular
Reason for recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
FDA root cause: Under Investigation by firm
Action: Baxter issued an Urgent Medical Device Recall notice to its consignees on 02/08/2024 via US mail. The notice explained the problem, hazard involved, and requested the following actions be taken: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. 2. 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 received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed 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 distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal.
Quantity in commerce: 26,592 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1291-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1291-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14

Product code FPA

K180739Class IIClearlink System Solution SetBaxter Healthcare Corporation / cleared 2019-05-28

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)