Z-1653-2022Class I

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection...

Name: Z-1653-2022 Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection...
Creator: Baxter Healthcare Corporation
Published: 2022-08-09
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-08-09 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site on 2022-08-09. FDA classified it as Class I and gives the reason as "Firm noted an increase in customer reports of leaks". 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-1653-2022
Classification: Class I
Status: Terminated
Initiated: 2022-08-09
Posted: 2022-09-14
Terminated: 2024-08-09
Recalling firm: Baxter Healthcare Corporation
Product: Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Firm noted an increase in customer reports of leaks.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Baxter notified their consignees by letter on 08/09/2022. The letter explained the issue, hazard, and provided the following instructions: "1. If no solution set leaks have been experienced, monitor the use of impacted solution sets closely (including during priming of the administration set and during bedside use) for issues as previously stated. 2. If any solution set leaks are experienced, cease use of the affected product and contact Baxter Corporate Product Surveillance at 800-437-5176 to report the complaint and to arrange for safe return of the product for further investigation. The product code and lot number can be found on the individual product pouch and carton. 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 have unused solution sets that you would like to return, 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. 4. Once Baxter has implemented corrective actions to resolve the issue, a follow-up notification will be sent to customers to provide additional instructions. 5. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 6. I
Quantity in commerce: 511,728 units
Distribution: US Nationwide Distribution
Product codes and lots: UDI/DI 00085412656649, All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1653-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1653-2022	Class I	Terminated	Voluntary: Firm initiated	2022-09-21	2022-09-09

Product code FPA

K112893Class IIClearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation / cleared 2011-10-18

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)