Recall Z-0914-2013— Churchill Medical Systems, Inc.

Name: FDA recall Z-0914-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-21

Class II · Terminated

Class II FDA medical device recall by Churchill Medical Systems, Inc., initiated 2013-01-21, terminated 2013-09-10. It names one FDA 510(k) clearance: K013871. 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..

Recalling firm: Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-21
Terminated: 2013-09-10
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K013871 — LIFEGUARD SAFETY INFUSION SETHorizon Medical Products, Inc.·cleared 2002-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.