Enforcement Report - Week of March 13, 2013
-
Back to Previous Page
Product Detail
| 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. |
|---|---|
| Recall Number | Z-0914-2013 |
| Classification | Class II |
| Code Info | Lot #1210099 |
| Product Distributed Qty | 2340 |
| Reason For Recall | 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. |
Event Detail
| Event Id | 64464 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Churchill Medical Systems, Inc. |
| City | Dover |
| State | NH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH. |
-
