Churchill Medical Recalls Lifeguard Infusion Sets Due to Labeling Error
Churchill Medical Systems is recalling 2,340 Lifeguard Infusion Sets because the labels incorrectly identify the needle gauge and item number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding the needle gauge and item number, which fits the criteria for moderate severity.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 2,340 units of the Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010. These are Huber type needle sets used for the infusion of medical fluids into implantable ports. The recall was initiated due to a labeling error on the device.
The product label incorrectly states that the item number is CLGY-2210 and that the pouch contains a 22-gauge set. In reality, the device is a 20-gauge set and the correct item number is CLGY-2010. The affected units are from Lot #1210099.
The recalled products were distributed nationwide, including in Missouri, Illinois, Florida, Pennsylvania, Virginia, New York, Nebraska, New Hampshire, and Ohio. Consumers and healthcare providers should stop using the affected infusion sets and contact Churchill Medical Systems for further instructions.
The recalled product
- Product
- Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
- Manufacturer
- Churchill Medical Systems, Inc.
- Category
- Medical Device — Infusion Set
- Hazard
- Affected units
- 2,340
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)
- Lot #1210099
Distribution
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