Churchill Medical Systems Recalls Bifurcated Extension Sets Due to Leaking Risk
Churchill Medical Systems is recalling 100 Bifurcated Extension Sets because a defect may cause leaking. The sets are used to administer medical fluids.
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 involves a medical device with a risk of harm (leaking) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 100 units of the Bifurcated Extension Set, Product Code BN-828. This accessory device is 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 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 Bifurcated Extension Sets immediately. The source text does not provide specific instructions for disposal or replacement, but users should contact the manufacturer or their medical supply provider for further guidance.
The recalled product
- Product
- Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 100
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)
- 1311080
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
Same manufacturer · Churchill Medical Systems, Inc.
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- HighChurchill Medical Systems Recalls 8 Inch Standard Bore Extension Sets
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk
FDA (Devices) · 2015-04-29
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