Churchill Medical Systems Recalls 7-Inch High Pressure Extension Sets
Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and 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) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 6,850 units of the 7" Standard Bore High Pressure Ext Set (Product Code: CMS-809). 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 specific lot codes involved are 1311028, 1311040, 1311041, 1407066, 1407197, 1408055, 1409055D, 1410048D, and 1410157D.
Healthcare facilities and consumers should stop using these specific extension sets and contact Churchill Medical Systems for instructions on how to return or replace the affected units.
The recalled product
- Product
- 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Affected units
- 6,850
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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