Churchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk
Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors 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 the hazard involves a risk of harm (leaking) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 1,050 units of Bifurcated set with check vales and Bionectors, Product Code BN-2082CV. These are accessory devices used to administer medical fluids. The recall is due to a potential for leaking caused by 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 source text does not specify the exact number of units distributed in each state or the specific dates of distribution.
Consumers and healthcare facilities should stop using the affected products immediately. Churchill Medical Systems is the recalling firm. The source text does not provide specific instructions on how to return the products or contact the manufacturer for a refund.
The recalled product
- Product
- Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 1,050
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 (1)
- 1303119 1305010 1306098 1305005
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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