Churchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets
Churchill Medical Systems is recalling 2,350 units of 4-inch Microbore Double Lumen Sets due to a potential leak caused by an insufficient bond 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 to administer fluids, 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 2,350 units of the 4" Microbore Double Lumen Set with Bionector (Product Code: BN-208). 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 involved are 1303123, 1305003, 1305008, 1305049, and 1306097.
Healthcare facilities and consumers should stop using the affected devices and contact Churchill Medical Systems for further instructions or a replacement.
The recalled product
- Product
- 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 2,350
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)
- 1303123 1305003 1305008 1305049 1306097
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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