Recall Z-0914-2013 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
| Date | Mar 6, 2013 (initiated Jan 21, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 o |
| Quantity | 2340 |
| Distribution | Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013871 | LIFEGUARD SAFETY INFUSION SET Horizon Medical Products, Inc., Mar 29, 2002 |