On September 15, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s recall of Clearlink basic solution set with Duovent because of reports of leaks. FDA identified it as a class I recall, the most serious type of recall, where use of the set may cause serious injuries or death.
Baxter Healthcare Corporation received 83 reports of leaks, none of which were associated with injuries or death. The recall affects 511,728 sets distributed from October 14, 2020–June 30, 2022. The recalled product code is 2R8403.
FDA explained that because a majority of the solution sets are used for delivery of hazardous drugs (e.g., chemotherapy), leakage could expose healthcare personnel, patients, and others to drugs that may be toxic or are irritants. Leaks may also allow air into the set or breach the sterile fluid pathway, increasing the risk of air embolism and contaminated infusions, or reduce or delay delivery of medication, potentially leading to serious injury or death.
Baxter Healthcare Corporation sent a notice to customers in August 2022 and recommended the following actions:
- Monitor the use of affected solution sets closely for leaks.
- Stop using the affected product if it leaks.
- Respond through the Baxter Healthcare Corporation customer portal to acknowledge receipt of notice.
- Contact your distributor according to their instructions.
- Inform any of your facilities or departments that are using the product.
- For dealers, wholesalers, distributors or resellers, or original equipment manufacturers: Conduct a consumer-level recall of any affected product distributed to customers and check the associated box on the customer portal.
Baxter Healthcare Corporation also recommended contacting its corporate product surveillance team at 800-437-5176 to report any leakages and to arrange to return defective products for further investigation. To return unused recalled solution sets, contact Baxter Healthcare Center for Service at 888-229-0001, Monday–Friday from 7 am–6 pm CT.
FDA said that Baxter will send a follow-up notice with additional instructions when the corporation implements corrective actions to resolve the issue.
Customers with questions about the recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday–Friday from 8 am–5 pm CT.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experience using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.