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U.S. Department of Health and Human Services

Class 1 Device Recall CLEARLINK System NonDEHP Solution Set with DUOVENT Spike

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 Class 1 Device Recall CLEARLINK System NonDEHP Solution Set with DUOVENT Spikesee related information
Date Initiated by FirmAugust 09, 2022
Date PostedSeptember 14, 2022
Recall Status1 Terminated 3 on August 09, 2024
Recall NumberZ-1653-2022
Recall Event ID 90730
510(K)NumberK112893 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBaxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Code Information UDI/DI 00085412656649, All lots within expiry
Recalling Firm/
Manufacturer
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Firm noted an increase in customer reports of leaks.
FDA Determined
Cause 2
Process design
ActionBaxter 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
Quantity in Commerce511,728 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FPA
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