Churchill Medical Systems Recalls 4-inch Microbore Trifurcated Extension Sets
Churchill Medical Systems is recalling 2,200 units of 4-inch Microbore Trifurcated Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.
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 product (medical device leak) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 2,200 units of the 4" Microbore Trifurcated Ext set, Product Code BN-308. 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 specific lot codes associated with this recall are 1303120, 1305002, and 1306099.
Healthcare facilities and consumers should stop using the affected extension sets and contact Churchill Medical Systems for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 2,200
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)
- 1303120 1305002 1306099
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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