Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lifeguard Infusion Set with Smartsite Recalled by Churchill Medical Systems, Inc. Due to The label on the device states that the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Churchill Medical Systems, Inc. directly.
Affected Products
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Quantity: 2340
Why Was This Recalled?
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Churchill Medical Systems, Inc.
Churchill Medical Systems, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report