FDA Class I Recall: Baxter Healthcare Corporation’s Clearlink Basic Solution Set with Duovent
The FDA has identified Baxter Healthcare Corporation’s recalls of the Clearlink Basic Solution Set with Duovent as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
Product Name: Clearlink Basic Solution Set with Duovent
· Product Code: 2R8403 (all lots within expiry)
· Devices in U.S. Distribution: 511,728
· Dates distributed: October 14, 2020 to June 30, 2022
· Date Initiated by Firm: August 9, 2022
Device Use
The Clearlink Basic Solution Set with Duovent is used as part of a system to administer drugs and solutions to patients. The majority of the Clearlink Basic Solution Sets with Duovent are used for the delivery of hazardous drugs (chemotherapy).
Reason for Recall
Baxter Healthcare Corporation is recalling Clearlink Basic Solution Set with Duovent after increased customer reports of leaks.
As the majority of the Clearlink Basic Solution Sets with Duovent are used for the delivery of hazardous drugs (chemotherapy), leakage could expose healthcare personnel, patients, and others to potentially hazardous drugs that may be toxic and/or are irritants. These leaks may also allow air into the set or breach the sterile fluid pathway, thereby increasing the risk of air embolism and contaminated infusions, respectively. Patients may suffer delayed or interrupted therapy or may not receive the necessary amount of their medication. These issues could lead to serious injury or death.
There have been 83 complaints with no injuries and no deaths associated with this issue.
Who May Be Affected
· Health care providers who administer fluids and medications using the Clearlink Basic Solution Set with Duovent.
· Patients who receive medications and fluids administered using the Clearlink Basic Solution Set with Duovent.
· People in close proximity to the Clearlink Basic Solution Set with Duovent that has leaked.
What to Do
On August 9, 2022, Baxter Healthcare Corporation issued an Urgent Medical Device Recall letter to customers informing them of the issue. The letter also offered the following recommended actions:
· Monitor the use of impacted solution sets closely (including during priming of the administration set and during beside use) for leaks.
· Stop use of affected products if leaks are experienced 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. Have the Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling.
· To return unused solution sets, contact Baxter Healthcare Center for Service 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. Have the Baxter 8-digit ship- to account number, product code, lot number, and quantity of product to be returned ready when calling.
· Acknowledge receipt of the letter by responding through the customer portal https://BaxterFieldActionCustomerPortal.onprocess.comExternal Link Disclaimer, even if there is no inventory. Acknowledging receipt will prevent repeat notices.
· If product was purchased from a distributor, do not respond on the Baxter customer portal--respond to the supplier according to their instructions.
· Forward a copy of the communication to any facilities or departments that have received this product.
· Dealers, wholesalers, distributors/resellers, or original equipment manufacturers (OEM) should conduct a consumer-level recall of any affected product distributed to customers and check the associated box on the customer portal.
When Baxter implements corrective actions to resolve the issue, a follow-up notification will be sent to customers with additional instructions.
