Skip to content

CLEARLINK recallZ-1653-2022 · Baxter Healthcare Corporation · initiated Aug 9, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Firm noted an increase in customer reports of leaks.

FDA root cause category: Process design

What the company is doing

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

Recall details

Recall number
Z-1653-2022
Status
Terminated
Initiated by the company
Aug 9, 2022
Posted by the FDA
Sep 14, 2022
Recalling firm
Baxter Healthcare Corporation
Quantity
511,728 units
Product code
FPA
FDA submissions
K112893
Distribution
US Nationwide Distribution

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 00085412656649, All lots within expiry

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

20 devices cleared under K112893 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page