Churchill Medical Systems Recalls 4-inch Trifurcated Sets Due to Leaking Risk
Churchill Medical Systems is recalling 2,650 units of 4-inch trifurcated sets with Bionectors and check valves due to a potential for leaking caused by insufficient bonding.
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: The recall is classified as FDA Class II and involves a risk of harm (leaking) in a medical device where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 2,650 units of 4-inch trifurcated sets with Bionectors and check valves (Product Codes BN-3082CV and BN-3083CV). These accessory devices are used to administer medical fluids. The recall is due to a potential for leaking caused by an insufficient bond between the needleless device and the female luer.
The affected products were distributed nationwide, including in Texas, Ohio, New York, California, Utah, Pennsylvania, Massachusetts, Virginia, and Illinois. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers should stop using the affected devices and contact Churchill Medical Systems for further instructions or a return.
The recalled product
- Product
- 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 2,650
Distribution
Part of a larger recall action
This product is one of 12 recalled by Churchill Medical Systems, Inc. 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.
See all 12 products in this recall →Related recalls
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