CLEARLINK Solution Set Adapter recalled for potential drip chamber leaks
Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with potential for patient harm due to solution leakage during infusion. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling the CLEARLINK Non-DEHP Solution Set Luer Lock Adapter (Product Code 2R8401) because of potential leaks originating from the drip chamber. This device is used to connect intravenous solution containers to infusion lines.
The defect could result in solution leaking during administration. The affected product includes Lot Number R23A02062 with an expiration date of January 1, 2025, and comprises 26,592 units distributed nationwide in the United States.
Barrier Healthcare recommends that healthcare facilities immediately stop using the recalled adapter and remove it from inventory. Healthcare providers should contact Baxter Healthcare for information regarding replacement products and proper handling of affected units.
The recalled product
- Product
- CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 26,592
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 00085412565767
- Lot Number R23A02062
- exp. 1 Jan 2025
Distribution
Distributed nationwide across the United States.
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