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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter CLEARLINK

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  Class 2 Device Recall Baxter CLEARLINK see related information
Date Initiated by Firm February 08, 2024
Date Posted March 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1291-2024
Recall Event ID 93930
510(K)Number K180739  
Product Classification Set, administration, intravascular - Product Code FPA
Product CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Code Information UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025
Recalling Firm/
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
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 Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 26,592 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = Baxter Healthcare Corporation