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.
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 2/5 (Moderate).
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
Related recalls
Same manufacturer · Churchill Medical Systems, Inc.
See all →- HighChurchill Medical Systems Recalls 4-inch Microbore Trifurcated Extension Sets
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 6-Inch Trifurcated Extension Sets for Leaking Risk
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 8 Inch Standard Bore Extension Sets
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk
FDA (Devices) · 2015-04-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighChurchill Medical 4-inch Microbore T-Port Set Recalled for Leaking Risk
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 4-inch Microbore Trifurcated Extension Sets
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets
FDA (Devices) · 2015-04-29
- HighChurchill Medical Systems Recalls 4-inch Trifurcated Sets Due to Leaking Risk
FDA (Devices) · 2015-04-29
- ModerateVygon Recalls 210 CT PICC Kits Packaged with Incorrect Needles
FDA (Devices) · 2013-03-20
- ModerateCareFusion Recalls SmartSite Infusion Sets Due to Tubing Assembly Error
FDA (Devices) · 2013-12-11