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CLEARLINK recallZ-1291-2024 · Baxter Healthcare Corporation · initiated Feb 8, 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

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1291-2024
Status
Open, Classified
Initiated by the company
Feb 8, 2024
Posted by the FDA
Mar 14, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
26,592 units
Product code
FPA
FDA submissions
K180739
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025

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.

Sources and updates

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