Churchill Medical Systems Recalls 7-Inch High Pressure Sets Due to Leaking Risk
Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.
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 is classified as FDA Class II, and the hazard involves a risk of harm (leaking) in a medical device where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 129,500 units of the 7" High Pressure Set with Bionector, Product Codes CMS-808 and CMS-808-1. 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 recall covers specific lot codes ranging from 1303184 to 1410156D.
Healthcare facilities and consumers should stop using the affected products and contact Churchill Medical Systems for further instructions or a replacement.
The recalled product
- Product
- 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 129,500
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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