Filtered extension sets recalled across two lots because IV sets may leak
Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots 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 non-DEHP Extension Sets, straight-type, standard bore, with a 1.2 micron filter and a CLEARLINK luer activated valve, 19 inches (47 cm), product code 2H8603, are being recalled because the IV sets may leak.
The recall covers 69,936 units carrying UDI/DI 00085412046433, from lots R25C26154 and R25C27079. 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 Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV set
- Affected units
- 69,936
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 00085412046433
- Lot numbers: R25C26154 and R25C27079
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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