FDA Device recall 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 po…
- FDA Device
- Class II
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class II recall of Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable po… by Churchill Medical Systems, citing 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 prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0914-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-21 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Churchill Medical Systems |
| Distribution | US |
Product
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
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.
Identifiers
| code_info | Lot #1210099 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0914-2013%22
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