Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 recallZ-0914-2013 · Churchill Medical Systems, Inc. · initiated Jan 21, 2013
Class II Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Churchill Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at [email protected]. For questions regarding this recall call 603-743-5988.
Recall details
- Recall number
- Z-0914-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 21, 2013
- Posted by the FDA
- Mar 6, 2013
- Recalling firm
- Churchill Medical Systems, Inc.
- Quantity
- 2340
- Product code
- FPA
- FDA submissions
- K013871
- Distribution
- Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
Product description
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Code information (models, lots, serial numbers)
Lot #1210099
Other devices under the same FDA submission
3 devices cleared under K013871 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Lifeguard LG-20-150Navilyst Medical, Inc. · Set, administration, intravascular2 reports
- VYGON CLG-2034Vygon Corporation · Set, administration, intravascular1 report
- Lifeguard LG-20-75Navilyst Medical, Inc. · Set, administration, intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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