Paclitaxel infusion sets recalled from one lot because IV sets may leak
Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot 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 Paclitaxel Sets, non-vented, with polyethylene lined tubing, a CLEARLINK luer activated valve, a 0.2 micron filter, a further CLEARLINK luer activated valve, 10 drops/mL, 107 inches (2.7 m), product code 2R8858, are being recalled because the IV sets may leak.
The recall covers 27,072 units carrying UDI/DI 00085412565774, from lot R25A13024. 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 lot should quarantine it and follow Baxter's instructions.
The recalled product
- Product
- CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV set
- Affected units
- 27,072
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 00085412565774
- Lot numbers: R25A13024
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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