Churchill Medical Systems Recalls 6-inch Trifurcated Sets with Bionectors
Churchill Medical Systems is recalling 1,650 6-inch trifurcated sets with Bionectors due to a potential leak caused by insufficient bonding between the needleless device and the female luer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a potential leak in a medical device used for fluid administration, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 1,650 units of the 6" Trifurcated set with Bionectors, Product Code BN-944. 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 source text does not specify any reported injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and consumers should stop using the affected products and contact Churchill Medical Systems for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 1,650
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)
- 1310051 1312063
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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