Baxter CLEARLINK System Non-DEHP Solution Set recalled due to leak reports
Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device classification establishes a minimum severity of 4 per the rubric. The source contains no reports of injuries, hospitalizations, or deaths, so the severity does not meet the criteria for a score of 5 (Critical).
Plain-English summary
Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set with DUO-VENT Spike (Product Code 2R8403) nationwide. This medical device is an in-line injection site set.
The company initiated this recall after noting an increase in customer reports of leaks. This FDA Class I recall affects approximately 511,728 units distributed across the United States. The affected product is identified by UDI/DI 00085412656649, and the recall applies to all lots currently within their expiry date.
Healthcare facilities and providers using this product should contact Baxter Healthcare Corporation for additional information regarding this recall and available alternatives.
The recalled product
- Product
- Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 511,728
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 (2)
- UDI/DI 00085412656649
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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