—#205944

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K180739
Affected lot / code info: UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-02-08
Posted by FDA: 2024-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205944. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.