Forty four inch extension sets recalled because the IV sets may leak
Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension 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 Extension Sets, straight-type, standard bore, with a CLEARLINK luer activated valve and retractable collar, 44 inches (111 cm), product code 2C8610, are being recalled because the IV sets may leak.
The recall covers 15,552 units carrying UDI/DI 00085412048963, from lot R25C31024. 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 EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV set
- Hazard
- leak
- device-defect
- intravenous
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 00085412048963
- Lot numbers: R25C31024
Distribution
Distributed nationwide across the United States.
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