Retractable collar solution sets recalled across many lots because sets may leak
Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
What this means for you
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: Scored 3 under the risk-of-harm criterion: a leaking intravenous set can interrupt delivery of fluids or medicines, and no injuries are reported.
Plain-English summary
CLEARLINK System Continu-Flo Solution Sets, non-vented, with three CLEARLINK luer activated valves, a backcheck valve and a retractable collar, 10 drops/mL, 120 inches (3.0 m), product code 2C8537, are being recalled because the IV sets may leak.
The recall covers 958,351 units carrying UDI/DI 00085412048970, across lots including R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017 and R25C18024. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record states the leak potential and reports no injuries. Facilities holding the affected lots should quarantine them and follow Baxter's instructions.
The recalled product
- Product
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV set
- Affected units
- 958,351
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 (14)
- UDI/DI 00085412048970
- Lot numbers: R25A13055
- R25B24024
- R25B25154
- R25C05017
- R25C13147
- R25C18017
- R25C18024
- R25C25116
- R25C26093
- R25C31079
- R25D03055
- R25D12123
- R25D19024
Distribution
Part of a larger recall action
This product is one of 16 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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