The U.S. Food and Drug Administration has issued labeled Baxter’s Clearlink Basic Solution Set with Duovent recall as a Class I recall due to a potential risk of leaking toxic chemicals leading to severe medical complications. The recall report states that Baxter Healthcare Corporation’s recall of its Clearlink Basic Solution Set with Duovent can expose both doctors and patients to toxic substances leading to injury or death. The recall affects all lots with a product code 2R8403 and all expiration dates. More than 511,700 of these sets have been distributed throughout the United States from October 14, 2020, until June 30, 2022.
The recall report states that the Clearlink Basic Solution Set with Duovent is used to administer solutions and medications to patients. Most of the Clearlink Basic Solution Sets with Duovent are used for the delivery of hazardous medications used in chemotherapy.
According to Baxter Healthcare Corporation, its Clearlink Basic Solution Set with Duovent is being recalled due to an increased number of customer reports of dangerous chemical leakage. Moreover, these leaks could also permit air to contaminate the sets or breach the sterile fluid pathway. Should those events happen, there is an increased risk of air embolism and contaminated infusions resulting in patients experiencing delayed or interrupted therapy. Patients could also experience not receiving the critical amount of medication they need. The recall announcement states that these issues can lead to severe injury or death.
So far, there have been more than 80 adverse incident complaints. No injuries or deaths have been reported at this time.
Who Could Be Affected
- Medical professionals who administer medications and fluids using Baxter’s Clearlink Basic Solution Set with Duovent.
- Patients who receive drugs and fluids using the Clearlink Basic Solution Set with Duovent.
- People near the Clearlink Basic Solution Set with Duovent, which has leaked.
Baxter Healthcare Corporation disseminated an Urgent Medical Device Recall letter to its customers, advising them of the leakage problem.
That letter also proposed the following suggested actions:
- Monitor the use of these solution sets closely for leaks.
- Discontinue the use of the recalled products if there are leaks and contact Baxter Corporate Product Surveillance to report and arrange the product’s safe return. When contacting Baxter, have the 8-digit ship-to account number, lot number, product code, and quantity to be returned.
- To return unused solution sets, contact Baxter Healthcare Center for Service and have the Baxter 8-digit ship-to account number, the quantity of product to be returned, product code, and lot number ready.
- Acknowledge receiving Baxter’s letter by replying through the customer portal.
- If the recalled product was purchased from one of their distributors, respond to the supplier using their instructions.
- Forward any copies of communications with any facilities or departments that have received the recalled products.
- Wholesalers, dealers, distributors, resellers, or original equipment manufacturers (OEM) need to conduct a consumer-level recall of the affected products.
Baxter stated that it would implement corrective actions to correct the problem, and a follow-up notification with additional instructions would be mailed to all customers.
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