Churchill Medical 4-inch Microbore T-Port Set Recalled for Leaking Risk
Churchill Medical Systems is recalling 450 units of 4-inch Microbore T-Port Sets due to a potential leak caused by insufficient bonding between components.
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 no injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 450 units of the 4" Microbore T-Port Set, Product Code BN-448. This accessory device is used to administer medical fluids. The recall was initiated because of 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 dates of distribution or the specific facilities where the products were shipped.
Consumers and healthcare facilities should stop using the affected T-Port Sets and contact Churchill Medical Systems for instructions on how to return or dispose of the products. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Affected units
- 450
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)
- 1303181 1303100 1304183
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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- HighChurchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets
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