Recalls / —

—#195582

Product

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

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K112893

Affected lot / code info

UDI/DI 00085412656649, All lots within expiry

Why it was recalled

Firm noted an increase in customer reports of leaks.

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US Nationwide Distribution

Timeline

Recall initiated

2022-08-09

Posted by FDA

2022-09-14

Terminated

2024-08-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #195582. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.