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CLEARLINK/CONTINU-FLO/DUO-VENT recallZ-1010-2025 · Baxter Healthcare Corporation · initiated Dec 20, 2024

Open, Classified

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

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

FDA root cause category: Process control

What the company is doing

Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/20/2024. The notice explained the problem with the device, hazard involved and requested the following: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. The product code and lot number can be found on the individual product and shipping carton. 2. Contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday to arrange for return and credit. 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 contact your supplier to arrange for return of the affected product. 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. Please forward a copy of this communication to the Medical Director/Office Manager, Director of Pharmacy, Medication Safety Officer, Purchasing Director/Head of central supply and any other departments within your institution who use the affected product. 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. For general questions regarding this co

Recall details

Recall number
Z-1010-2025
Status
Open, Classified
Initiated by the company
Dec 20, 2024
Posted by the FDA
Jan 22, 2025
Recalling firm
Baxter Healthcare Corporation
Product code
FPA
FDA submissions
K180739
Distribution
US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.

Product description

Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

Code information (models, lots, serial numbers)

UDI/DI 00085412676647, Lot Numbers: DR24C15109 (exp. 3/16/2026)

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

7 devices cleared under K180739 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95929).

Sources and updates

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