FDAFDA · Food and drugs·Recall number Z-0914-2013
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Published March 13, 2013 · Recall initiated: January 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Churchill Medical Systems, Inc.
- Distributor
- Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
- Lot
- Lot #1210099
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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