Churchill Medical Systems Recalls 8 Inch Standard Bore Extension Sets
Churchill Medical Systems is recalling 8-inch Standard Bore Extension Sets 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, and the hazard involves a risk of harm (leaking of medical fluids) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 8-inch Standard Bore Extension Sets, identified by Product Code BN-481. These accessory devices are used to administer medical fluids. The recall is due to a potential for leaking caused by 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 total quantity of units recalled or the specific dates of distribution.
Consumers and healthcare facilities should stop using the affected extension sets and contact Churchill Medical Systems for further instructions or a replacement.
The recalled product
- Product
- 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
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)
- 1304129 1305051
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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