Churchill Medical Systems Recalls 6-Inch Trifurcated Extension Sets for Leaking Risk
Churchill Medical Systems is recalling 5,200 6-inch trifurcated extension sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.
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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 5,200 units of the 6" Trifurcated Extension Set, Product Code AMS-375-1. This accessory device is 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 associated with this recall are 1304035, 1407046, and 1410111D.
Healthcare facilities and consumers should stop using these extension sets and contact Churchill Medical Systems for further instructions or a replacement.
The recalled product
- Product
- 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 5,200
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 (3)
- 1304035
- 1407046
- 1410111D
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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